78 Draft risk based classification list Cardiovascular and Neurological dated 01 04 2025 for stakeholder comments 2025-Apr-01 1014 KB
In force — no superseding record on file.
Annexure I (Reference File No.: MED-16015(11)/1/2025-eoffice) CATEGORIES OF MEDICAL DEVICES FOR RISK-BASED CLASSIFICATION
S. No. Categories of Medical Devices 1. Cardiovascular 2. Neurological
Note: All concerned associations/stakeholders are requested to forward their comments by filling the Google form at https://forms.gle/62xF3BtXWC5pgD3TA within 30 days from the date of publication of this draft.
Name of Category: Cardiovascular
Total No. of Devices: 351
Category: Cardiovascular
S.No. Device name
Intended use
Risk
class
1 Active-implantable-
device communicator
It is intended to communicate (e.g., via
radio-frequency) with an active MR-
conditional implantable device (e.g., a
pulse generator) to receive information on
device and/or physiologic performance,
and/or to select and actuate MRI settings.
Class D
2 Aneroid manual
sphygmomanometer
A device intended to measure blood
pressure consisting of a manually inflatable
cuff that fits around a limb (arm or thigh),
an inflation bulb for controlling the air
pressure within the cuff, an aneroid
manometer, and tubing.
Class B
3 Aortic annuloplasty ring
A circular band intended to be implanted in
the heart during open heart surgery to
support an aortic valve annulus for the
reconstruction and/or remodelling of an
insufficient aortic valve.
ring
A circular band intended to be implanted in
the heart during open heart surgery to
support an aortic valve annulus for the
reconstruction and/or remodelling of an
insufficient aortic valve.
Class D
4 Aortic bi-leaflet
mechanical heart valve
prosthesis
It is an artificial substitute for a natural
aortic heart valve intended to be implanted
during open heart surgery typically to treat
acquired or congenital valvular disease.
Class D
5 Aortic bi-leaflet
mechanical heart valve
prosthesis/biologic-
polymer aorta graft
An artificial substitute for a natural aortic
heart valve fitted with a length of biologic-
polymer blood vessel (vascular graft)
intended to be implanted during open heart
surgery to simultaneously replace a
dysfunctional aortic heart valve and
repair/replace a damaged or diseased
ascending aorta (e.g., in cases of
aneurysm, dissection or dilatation).
Class D
6 Aortic heart valve
bioprosthesis
A xenograft (e.g., porcine or bovine heart
valve) intended to be implanted in a patient
during open heart surgery to repair or
replace a dysfunctional aortic heart valve.
Class D
7 Aortic transcatheter heart
valve bioprosthesis,
stent-like framework
An implantable xenograft (e.g., bovine,
porcine) intended to be used to
repair/replace a stenosed and/or
regurgitant aortic heart valve, or previously-
implanted aortic heart valve prosthesis, and
which is designed to be implanted with a
catheter via transarterial access (e.g.,
femoral, subclavian, aortic) or transapical
access while the heart is beating.
Class D
rt valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. Class D
8 Apexcardiograph (vibrocardiograph) An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer. Class B 9 Apheresis Kit Intended for the collection and separation of blood components Class C 10 Arrhythmia Detector And Alarm (Including St- Segment Measurement And Alarm) The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. Class C 11 Arterial cannula Inserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat- to-beat blood pressure and to draw repeated blood samples. Class D 12 Arterial catheter Intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature.
blood samples.
Class D
12 Arterial catheter
Intended to be used in conjunction with
steerable guidewires in order to access
discrete regions of the coronary and
peripheral arterial vasculature.
Class D
13 Arteriovenous shunt
An implanted device intended to provide a
passage for blood to flow between an
artery typically located in an arm, and a
peripheral vein, central vein or right atrium,
creating a graft fistula that provides blood
access for external procedures, especially
haemodialysis.
Class D
14 Atherectomy coronary
catheter
A catheter containing a rotating cutter a
collecting chamber for debris, used for
atherectomy and endarterectomy.
Class D
15 Atherectomy laser
system beam guide-
catheter, coronary
It is intended to be connected to an
atherectomy laser system to invasively
direct and deliver laser energy into the
coronary arteries for the ablation of
atherosclerotic plaques in completely
occluded vessels.
Class D
16 Atherectomy peripheral
catheter
Intended for use in atherectomy of the
peripheral vasculature.
Class D
17 Automated external
defibrillator,
rechargeable/non-
rechargeable
This electronic device is intended to
automatically detect cardiac arrhythmias
(ventricular fibrillation/pulseless ventricular
tachycardia) in a sudden cardiac arrest
(SCA) patient, after which it audibly/visually
instructs an operator to enable it to activate
defibrillation of the heart through
application of electrical shocks to the chest
surface.
Class C
(SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. Class C
18 Automatic-inflation
electronic
sphygmomanometer,
professional use, non-
portable
An electronic device intended to be used in
indirect (noninvasive) measurement of
blood pressure using a self-contained
software program that regulates automatic
arm-cuff inflation and measurement cycles.
In addition to systolic and diastolic
pressures, it also usually displays heart
rate and mean arterial pressure.
Class B
19 Automatic-inflation
electronic
sphygmomanometer,
professional use,
portable
A portable device designed to
noninvasively measure blood pressure
using a self-contained software program
that regulates automatic arm/wrist-cuff
inflation and measurement cycles. It
typically displays current heart rate and
mean arterial pressure in addition to
systolic and diastolic blood pressures.
Class B
20 Ballistocardiograph
cardiac output
unit
A device used to record the body
movement (toward the head and feet)
caused by cardiac protrusion when blood is
ejected by cardiac contraction.
Class B
21 Balloon dilatation vessel
catheter
Intended for use in Percutaneous
Transluminal Angioplasty (PTA) of the
renal, tibial, popliteal, femoral and peroneal
arteries. These catheters are not for use in
coronary arteries.
catheter
Intended for use in Percutaneous
Transluminal Angioplasty (PTA) of the
renal, tibial, popliteal, femoral and peroneal
arteries. These catheters are not for use in
coronary arteries.
Class B
22 Bare-metal coronary
artery stent
A non-bioabsorbable stent intended to be
implanted in a coronary artery or
saphenous vein graft of the heart to
maintain luminal patency and improve
luminal diameter typically in a patient with
symptomatic atherosclerotic heart disease.
Class D
23 Bifurcation stent
Intended for improving the side branch
luminal diameter of arterial bifurcation
liaisons.
Class D
24 Biventricular pacemaker
An MR conditional pulse generator,
intended to be implanted in the chest and
used with pacing leads placed in the and
around the heart to stimulate the heart to
beat at a faster rate when it senses
bradycardia and provides cardiac
resynchronization therapy (CRT) through
biventricular electrical stimulation to
synchronize right and left ventricular
contractions to treat symptoms of heart
failure (e.g., easy fatigue) and serious
heart-rhythm problems [CRT pacemaker
(CRT-P)]; it is not intended for defibrillation
therapy.
Class D
ntricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy. Class D
25 Biventricular
pacemaker/defibrillator
An MR conditional, implantable device
intended to provide cardiac
resynchronization therapy (CRT) through
biventricular electrical stimulation to
synchronize right and left ventricular
contractions for more effective blood
pumping to treat symptoms of heart failure
(e.g., shortness of breath, easy fatigue)
and serious heart-rhythm problems [CRT
defibrillator (CRT-D)]. It enables
conventional pacing and defibrillation
functions also.
Class D
26 Cardiac ablation laser
system beam guide-
catheter
A steerable catheter intended to be used
as part of a cardiac ablation laser system to
invasively direct and deliver laser energy to
the endocardium of a beating heart for the
ablation of specific areas in the treatment
of cardiac arrhythmias. It is intended to be
introduced into the heart via venous access
(e.g., femoral vein).
Class D
27 Cardiac ablation solid-
state laser system
A device assembly in which input energy
(e.g., flashlamp, diode laser) is used to
excite a doped glass/crystal medium to
emit a high-power laser beam intended for
endocardial ablation procedures for the
treatment of atrial fibrillation.
e.g., flashlamp, diode laser) is used to
excite a doped glass/crystal medium to
emit a high-power laser beam intended for
endocardial ablation procedures for the
treatment of atrial fibrillation. A laser beam
guide catheter and angioscope may be
included
Class D
28 Cardiac ablation system
applicator
introducer/sizer
It is a flexible device intended to determine
the appropriate size of a cardiac tissue
ablation system applicator [to determine
the appropriate number of transducers
(ablation cells) required to treat the target
tissue] and/or used to introduce and guide
it into position, or used to help fix the
applicator in position.
Class C
29 Cardiac ablation system
irrigation tubing set
A set consisting of sterile flexible tubing
and associated items that may include
clamps, filters, and connectors, intended to
deliver irrigation and/or cooling solution
(saline) to an ablation device (e.g., an
ablation catheter or a cardiac tissue
ablation system applicator) at a specified
flow rate during a cardiac electrophysiology
(EP) ablation procedure.
Class B
30 Cardiac ablation thoracic
motion sensor
A small electronic device intended to be
placed on a patient’s chest during a cardiac
ablation procedure to sense diaphragmatic
movement as a means to assess potential
phrenic nerve damage.
Class B
ll electronic device intended to be
placed on a patient’s chest during a cardiac
ablation procedure to sense diaphragmatic
movement as a means to assess potential
phrenic nerve damage.
Class B
31 Cardiac arrest
hypothermia kit
A collection of devices intended to lower
the core body temperature of a patient in
the short term following a cardiac arrest
event to induce and sustain mild
hypothermia for improvement of
neurological and cognitive prognoses. It
typically includes blankets, caps, axilla
pads and groin pads, which are filled with a
thermally-retentive material (e.g., non-toxic
polymer gel) that can be cooled in a
freezer.
Class B
32 Cardiac catheterization
kit
Cardiac catheterization is a general term
for a group of procedures that are
performed using this method, such as
coronary angiography and left ventricle
angiography.
Class C
33 Cardiac catheterization
laboratory computer
A dedicated computer intended to
calculate, store, and analyse
haemodynamic parameters, and other
cardiac-related measurements, based on
data from catheterization laboratory
monitoring/recording. Such data can be
pressure measurements that are converted
into useful parameters, e.g., cardiac output,
pressure gradients, valve areas, shunt
flows, vascular resistance, diastolic filling
period or systolic ejection period.
surements that are converted
into useful parameters, e.g., cardiac output,
pressure gradients, valve areas, shunt
flows, vascular resistance, diastolic filling
period or systolic ejection period.
Class C
34 Cardiac catheterization
monitoring system
An assembly of devices intended to
continuously obtain, amplify, and record
various signals generated during
procedures usually performed in the
cardiac catheterization laboratory. The
system is intended to be used for
procedures such as left heart
catheterization, right heart catheterization
ventriculograms, coronary angiography,
and pacemaker insertions; also used in
procedures intended for the determination
of most haemodynamic characteristics,
evaluation of therapies, and planning of
surgical approaches.
Class D
35 Cardiac cryosurgical
system
A mobile assembly of mains electricity (AC-
powered) devices intended to cryogenically
ablate areas of the endocardium of a
beating heart in the treatment of cardiac
arrhythmias.
Class D
36 Cardiac cryosurgical
system catheter (Cardiac
cryoablation balloon
catheter)
It is intended to be used as part of a
cardiac tissue cryosurgical system to
cryogenically ablate areas of the
endocardium of a beating heart in the
treatment of cardiac arrhythmias.
Class D
) It is intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. Class D
37 Cardiac cryosurgical
system remote control
A hand-operated electronic unit intended to
control the operational functions of a
cardiac cryosurgical system and its
components (e.g., cardiac tissue ablation
catheter) from a distance via a connected
cable or wirelessly, during a surgical
intervention.
Class C
38 Cardiac defect occluder
An implantable device intended to be used
for the minimally-invasive closure of
cardiac defects towards the treatment of
cardiac disorders that may include (but not
limited to) atrial septal defect (ASD),
ventricular septal defect (VSD), patent
foramen ovale (PFO), or patent ductus
arteriosus (PDA).
Class D
39 Cardiac electroacoustic
transducer
A device intended to be used to detect the
vibrations created by the heart's beating
and which are transmitted through organs
and tissue to the body surface.
Class B
40 Cardiac
electrophysiology
analysis system
An assembly of devices intended to
perform several diagnostic tests and
therapeutic treatments of the heart in
patients with arrhythmic or conduction
disorders, including analysis of the
atrioventricular conduction system,
defibrillator function, and/or the
induction/termination of ventricular
tachycardia.
tients with arrhythmic or conduction
disorders, including analysis of the
atrioventricular conduction system,
defibrillator function, and/or the
induction/termination of ventricular
tachycardia.
Class C
41 Cardiac
electrophysiology
stimulation system
An assembly of devices intended to deliver
precisely timed electrical impulses to the
heart, during spontaneous and paced
rhythms, for diagnostic cardiac stimulation.
It is intended to be used for performing
physiologic cardiac tests such as to
determine the function of various
components of the atrioventricular
conduction, factors required for induction
and termination of tachycardia, and/or to
assess sinus node function.
Class C
42 Cardiac
electrophysiology
workstation
It is a component of a cardiac
electrophysiology analysis system
consisting of monitor(s), printer(s) and/or
graphic recorder(s), data recorder (e.g.,
optical or magnetic disk), and plug-in
modules for signal amplification and/or
conditioning.
Class B
43 Cardiac insulation pad
It is intended to be placed around the heart
in conjunction with cold cardioplegia during
cardiac surgery with extracorporeal
circulation. The device is intended to help
to prevent rapid rewarming of the heart.
Class B
d around the heart
in conjunction with cold cardioplegia during
cardiac surgery with extracorporeal
circulation. The device is intended to help
to prevent rapid rewarming of the heart.
Class B
44 Cardiac irreversible electroporation system catheter It is intended to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to treat cardiac arrhythmia. It is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. Class D 45 Cardiac irreversible electroporation system generator A cardiac-dedicated device intended to generate microsecond electrical pulses to produce irreversible cell membrane electroporation and subsequent cell death for the selective nonthermal ablation of cardiac tissues. Class D 46 Cardiac mapping catheter, percutaneous, single-use A steerable device intended to transmit electrical impulses to the heart for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures.
endocardial recording, stimulation,
temporary pacing for evaluation of cardiac
arrhythmias, cardioversion (CV) of
electrical arrhythmias or electrophysiology
(EP) mapping of cardiac structures.
Class D
47 Cardiac mapping system
An assembly of devices intended to
measure, process, and store electronic
data for the interpretation of cardiac
physiological parameters received from the
output of connected measuring devices
(e.g., body surface or intracardiac
electrocardiograph (ECG) sensors,
transducers, and catheters).
Class C
48 Cardiac mapping system
application software
An individual software program or group of
programs, routines and/or algorithms
intended to add specific image processing
and/or analysis capabilities to a cardiac
mapping system computer for storing,
processing and management of electronic
information/data used to interpret cardiac
physiology parameters. It is a basic set of
application programs and routines used for
cardiac mapping computer-controlled
imaging which can be upgraded to correct
programming errors or to add new system
capabilities.
Class C
49 Cardiac mapping system
electrode array
A component of a cardiac mapping system
intended to be worn on the torso to transmit
cardiac bioelectric signals to the system for
storage, analysis and display of cardiac
electrophysiological data.
Class B
f a cardiac mapping system intended to be worn on the torso to transmit cardiac bioelectric signals to the system for storage, analysis and display of cardiac electrophysiological data. Class B
50 Cardiac mapping system
reference patch
A component of a cardiac mapping system
that is an adhesive device intended to be
placed on the surface of a patient's body to
provide a fixed reference point for the tip of
an internal, non-fluoroscopic catheter
during an electrophysiological and
electromechanical real-time mapping of the
heart. It may also be intended to
compensate for patient movement during
the procedure.
Class A
51 Cardiac mapping system
workstation
A mains electricity (AC-powered) device
intended as a control unit to
percutaneously navigate (orientate and
steer) a cardiac mapping system catheter,
or its associated guidewire, in the desired
direction to the designated target site (e.g.,
coronary vasculature).
Class C
52 Cardiac
mapping/endocardial-
injection catheter
A steerable device intended to be
introduced percutaneously into the heart
chambers to relay information to an
external cardiac mapping system to create
a three-dimensional (3-D)
electromechanical reconstruction map of
the heart chamber. The device may also
incorporate a small hollow needle intended
for targeted delivery of diagnostic and
therapeutic agents into the myocardium.
omechanical reconstruction map of
the heart chamber. The device may also
incorporate a small hollow needle intended
for targeted delivery of diagnostic and
therapeutic agents into the myocardium.
Class D
53 Cardiac monitor
(including
cardiotachometer and
rate alarm)
A cardiac monitor (including
cardiotachometer and rate alarm) is a
device used to measure the heart rate from
an analog signal produced by an
electrocardiograph, vectorcardiograph, or
blood pressure monitor. This device may
sound an alarm when the heart rate falls
outside preset upper and lower limits.
Class B
54 Cardiac occluder delivery
kit
A collection of devices intended to implant
a cardiac occluder (not included) for the
non-surgical closure of cardiac defects.
The kit may include a delivery
catheter/sheath, dilator, loading device,
delivery cable, and additional items for the
intravascular delivery and deployment of a
cardiac occluder.
Class D
55 Cardiac
occluder/interatrial shunt
transcatheter introducer
An implantable intended to be used for the
minimally-invasive closure of cardiac
defects and deployed using a dedicated
delivery catheter/sheath.
Class D
ratrial shunt transcatheter introducer An implantable intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. Class D
56 Cardiac pulse generator programmer An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. Class C 57 Cardiac pulse generator reader, home-use An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use.
in
addition be intended to communicate with a
diagnostic cardiac implant (e.g.,
implantable cardiac monitor); it is not
intended to program therapeutic implants
and is dedicated to cardiac use.
Class D
58 Cardiac pulse generator
reader, professional
An external device intended to enable a
healthcare professional in a clinical setting
to noninvasively extract data from an
implanted cardiac pulse generator (i.e.,
therapeutic active cardiac implant) to obtain
historic and/or current information on
device performance, and may in addition
be intended to communicate with a
diagnostic cardiac implant (e.g.,
implantable cardiac monitor); it is not
intended to program therapeutic implants
and is dedicated to cardiac use.
Class C
59 Cardiac pulse generator
software
An application or operating data program
(i.e., primarily operating system software
that may include some application program
functionality) intended for use in or with an
implantable cardioverter-defibrillator (ICD)
and an implantable cardiac pacemaker so
that the defibrillator and pacemaker
function according to their intended
purpose.
Class D
60 Cardiac pulse generator
test magnet
A magnetized device intended to be used
to test an inhibited or triggered type of
pacemaker or defibrillator, and cause an
inhibited or triggered generator to revert to
asynchronous operation.
A magnetized device intended to be used to test an inhibited or triggered type of pacemaker or defibrillator, and cause an inhibited or triggered generator to revert to asynchronous operation. It may also be intended to change the function of the implanted device (e.g., switching to preprogrammed mode or a non-detection mode where external power source may interfere with pacemaker/defibrillator function, etc.). Class C
61 Cardiac radio-frequency
ablation system catheter
A steerable catheter intended to be used
as part of a radio-frequency cardiac
ablation system to apply radio-frequency
alternating current to ablate areas of the
endocardium of a beating heart in the
treatment of cardiac arrhythmias; it is
typically also intended to transmit electrical
pacing stimuli to, and electrical responses
from, the heart for electrophysiological (EP)
mapping. It may contain monopolar and/or
bipolar ablation electrodes.
Class D
62 Cardiac radio-frequency
ablation system
generator
It is intended to be used to generate radio-
frequency energy to create ablative lesions
in the cardiac tissue of a beating heart in
the treatment of cardiac arrhythmias. It may
be intended to be used with a radio-
frequency catheter for endocardial ablation
and/or an epicardial probe for epicardial
ablation.
beating heart in the treatment of cardiac arrhythmias. It may be intended to be used with a radio- frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation. Class C 63 Cardiac resuscitator chest pad An electrically conductive device intended to be applied to the chest of a patient to provide a landing surface for a manual cardiac resuscitator during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. The device is intended to be used on adult patients only. Class B 64 Cardiac resuscitator, battery-powered/line- powered An external device intended to be used as an adjunct to or substitute of manual external cardiac compressions for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. Class C 65 Cardiac resuscitator, manual A manually-operated external device (a hand-powered pump) intended to be applied to the chest of a patient suffering cardiac arrest so that a healthcare professional or layperson can administer rhythmic compression to the chest in the region of the heart to provide blood flow during cardiopulmonary resuscitation (CPR).
rrest so that a healthcare professional or layperson can administer rhythmic compression to the chest in the region of the heart to provide blood flow during cardiopulmonary resuscitation (CPR). Class B 66 Cardiac resynchronization therapy implantable defibrillator An implantable device intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)]. Class D
67 Cardiac resynchronization therapy implantable pacemaker A hermetically-sealed pulse generator, intended to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy. Class D 68 Cardiac septostomy catheter, balloon It is intended to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. Class D 69 Cardiac sizing catheter/balloon It is intended for use in a patient with a cardiovascular defect wherein accurate measurement of the defect is important to select the appropriately sized occlusion device.
ing
catheter/balloon
It is intended for use in a patient with a
cardiovascular defect wherein accurate
measurement of the defect is important to
select the appropriately sized occlusion
device.
Class D
70 Cardiac stress exercise
table
Intended for measurements during cardiac
stress exercise.
Class A
71 Cardiac thermodilution
catheter
A catheter used in thermodilution for
introduction of the cold liquid indicator into
the cardiovascular system or for the
assessment of a patient’s hemodynamic
condition through simultaneous right atrial,
right ventricular, and pulmonary artery or
wedge pressure monitoring, cardiac output
determination, and for infusing solutions.
Class C
72 Cardiac transseptal
access electrosurgical
dilator/needle
It is an electrosurgical device intended to
be used with a transseptal vascular guide-
catheter (not included) to penetrate the
interatrial septum for left-heart access
during a transseptal catheterization
procedure.
Class D
73 Cardiac transseptal
access set
A collection of nonimplantable devices
intended to be used to puncture the
interatrial septum during a transseptal
catheterization procedure, and to create a
conduit for the introduction of various
cardiovascular catheters into the left side of
the heart. It includes a vascular guide-
catheter (referred to as a steerable
introducer) with a transseptal needle to
create the puncture, and may also include
additional introduction assistive devices
necessary for the procedure (e.g., stylet,
guidewire, dilator).
rable introducer) with a transseptal needle to create the puncture, and may also include additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). Class D 74 Cardiac transseptal needle, single-use A device intended to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and Class D
injection/infusion, blood sampling, and
pressure monitoring.
75 Cardiac valvuloplasty
catheter
A device intended to perform plastic or
restorative surgery on a cardiac valve, i.e.,
for the dilatation of atrioventricular, aortic,
and pulmonary trunk valves.
Class D
76 Cardiac ventriculography
catheter
A device intended to enter the left or right
ventricle to perform diagnostic
haemodynamic/angiographic procedures
with contrast media.
Class D
77 Cardiac/peripheral
vascular guidewire,
single-use
A device intended to be percutaneously
placed into the cardiac vasculature
(ventricles or coronary vessels) to function
as a guide for the introduction, positioning,
and/or operation of a device (e.g., catheter,
pacing lead); it may also be used in the
peripheral vasculature. It may include
devices used to facilitate manipulation
(e.g., torque device).
Class D
78 Cardiokymograph
An electrocardiograph that records heart
wall motion (mainly motion of the left
ventricular anterior wall) on an amplitude
vs. time graph (heart kymograph).
device).
Class D
78 Cardiokymograph
An electrocardiograph that records heart
wall motion (mainly motion of the left
ventricular anterior wall) on an amplitude
vs. time graph (heart kymograph).
Class B
79 Cardioplegia cannula
A device intended to deliver cardioplegic
solution to the aortic root to stop the
beating of the heart and maintain it
dormant; it may also be used to vent the
aorta and the left heart during a
cardiopulmonary bypass procedure.
Class C
80 Cardioplegia solution
administration adaptor
A device intended to facilitate/regulate the
delivery of cardioplegic solution to the heart
during a cardiopulmonary bypass
procedure by connecting an administration
line to a cardioplegia cannula.
Class B
81 Cardioplegia solution
administration kit
A collection of devices intended to be used
to infuse cardioplegia solution into the heart
to interrupt its contractions during
cardiopulmonary bypass surgery. It
typically consists of tubing/adaptor, a filter,
and a heat exchanger.
Class B
nfuse cardioplegia solution into the heart
to interrupt its contractions during
cardiopulmonary bypass surgery. It
typically consists of tubing/adaptor, a filter,
and a heat exchanger.
Class B
82 Cardiopulmonary bypass arterial line blood filter A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line. Class B 83 Cardiopulmonary bypass bubble detector A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit. Class B 84 Cardiopulmonary bypass cannula holder set A collection of devices intended to help secure a cardiopulmonary bypass cannula to the underlying tissue in the operative field to minimize displacement of the cannula during cardiopulmonary bypass surgery. Class B 85 Cardiopulmonary bypass cannula, femoral A device intended to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely.
pulmonary bypass procedures. The
tube is used in set-ups/systems intended to
divert the patient's blood to and from
external tubing and an arterial pump,
bypassing the heart and lungs completely.
Class D
86 Cardiopulmonary bypass
cardiotomy suction line
blood filter
A cardiopulmonary bypass cardiotomy
suction line blood filter is a device used as
part of a gas exchange (oxygenator)
system to filter nonbiologic particles and
emboli (a blood clot or a piece of foreign
material flowing in the bloodstream which
will obstruct circulation by blocking a
vessel) out of the blood. This device is
intended for use in the cardiotomy suction
line.
Class C
87 Cardiopulmonary bypass
defoamer
A cardiopulmonary bypass defoamer is a
device used in conjunction with an
oxygenator during cardiopulmonary bypass
surgery to remove gas bubbles from the
blood.
Class C
88 Cardiopulmonary bypass
heart-lung machine
console
A cardiopulmonary bypass heart- lung
machine console is a device that consists
of a control panel and the electrical power
and control circuitry for a heart-lung
machine. The console is designed to
interface with the basic units used in a gas
exchange system, including the pumps,
oxygenator, and heat exchanger.
Class B
control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger. Class B
89 Cardiopulmonary bypass
pulsatile flow generator
A cardiopulmonary bypass pulsatile flow
generator is an electrically and
pneumatically operated device used to
create pulsatile blood flow. The device is
placed in a cardiopulmonary bypass circuit
downstream from
the oxygenator.
Class B
90 Cardiopulmonary bypass
system blood gas
monitor, in-line
An assembly of devices intended to
monitor venous and arterial blood gas
parameters in cardiopulmonary bypass
procedures. It may be intended for adult
and/or pediatric population.
Class C
91 Cardiopulmonary bypass
system blood gas sensor
A transducer intended to be used with a
cardiopulmonary bypass system to detect
and measure the partial pressure of gases
in the blood being circulated by the system.
Class C
92 Cardiopulmonary bypass
system blood tubing set
A collection of devices consisting of tubing
and typically clamps, filters, connectors,
and stopcocks, used in a circuit for a
cardiopulmonary bypass procedure.
ry bypass
system blood tubing set
A collection of devices consisting of tubing
and typically clamps, filters, connectors,
and stopcocks, used in a circuit for a
cardiopulmonary bypass procedure.
Class C
93 Cardiopulmonary bypass
system centrifugal pump
A device intended to be connected to a
drive unit (not included) to circulate blood
through the extracorporeal circuit of a non-
roller type cardiopulmonary bypass system,
via a centrifugal force mechanism, for gas
exchange and reinfusion; it may in addition
be used in extracorporeal support systems
for ventricular support/circulatory
assistance.
Class C
94 Cardiopulmonary bypass
system centrifugal pump
drive unit
A device that powers and controls the
speed of a disposable cardiovascular
bypass system centrifugal pump, to which it
is connected, for the circulation of blood
through the extracorporeal circuit for gas
exchange and reinfusion. This device
drives the centrifugal rotor of the
disposable centrifugal pump using
magnetism.
Class B
95 Cardiopulmonary bypass
system filter, priming
solution
A porous, sterile device intended to be
used to filter the nonhaemic priming
solution used in the heart-lung bypass
extracorporeal circuit to remove
particulates or other debris from the circuit
prior to the initiation of the cardiopulmonary
bypass surgery procedure.
ing solution used in the heart-lung bypass extracorporeal circuit to remove particulates or other debris from the circuit prior to the initiation of the cardiopulmonary bypass surgery procedure. Class B 96 Cardiopulmonary bypass system filter, venous blood line (Blood transfusion filter) A microporous device intended to remove gross air in the venous line before it is entering the arterial pump and the components of the extracorporeal circuit (ECC). Class C
97 Cardiopulmonary bypass
system gas control unit
A device that is a module of a
cardiopulmonary bypass system and that is
intended to control and measure the flow of
gas supplied into the oxygenator.
Class C
98 Cardiopulmonary bypass
system heat exchanger,
reusable/single use
A device consisting of a heat exchanging
system intended to be used in
extracorporeal circulation to warm or cool
the blood or perfusion fluid flowing through
the device for the purposes of
cardiopulmonary bypass intervention or
treatment.
Class C
99 Cardiopulmonary bypass
system heat exchanger,
single-use
A device consisting of a heat exchanging
system intended to be used in
extracorporeal circulation to warm or cool
the blood or perfusion fluid flowing through
the device for the purposes of
cardiopulmonary bypass intervention or
treatment.
em intended to be used in
extracorporeal circulation to warm or cool
the blood or perfusion fluid flowing through
the device for the purposes of
cardiopulmonary bypass intervention or
treatment.
Class C
100 Cardiopulmonary bypass
system heating/cooling
unit
A mains electricity (AC-powered)
component of a cardiopulmonary bypass
system intended to heat or cool a patient's
body by extracorporeal heat exchange with
the patient's perfused blood during a
cardiopulmonary bypass procedure.
Class C
101 Cardiopulmonary bypass
system mounting unit
(heart-lung bypass
system module, console)
A platform upon which modular devices of
a cardiopulmonary bypass system (e.g.,
the blood pumps) are mounted to form the
complete system. It serves as the basic
workstation for the operator to monitor and
control the system's functions.
Class C
102 Cardiopulmonary bypass
system priming set
It is intended to be used in open heart
surgery to facilitate the transfer of priming
fluids during the priming of the
extracorporeal circuit of a cardiopulmonary
bypass system.
Class B
103 Cardiopulmonary bypass
system roller pump
A mains electricity (AC-powered) device
that is a module of a cardiopulmonary
bypass system and is intended to circulate
the blood flow outside of the body for gas
exchange and reinfusion via a roller type
mechanism. This pump can also be used to
deliver cardioplegia solution at a controlled
volume to the patient.
the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient. Class C 104 Cardiopulmonary bypass system valve, unidirectional flow/pressure control A mechanical regulator intended to be used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgeryto provide unidirectional flow, preventing inadvertent backflow of blood and air into the heart, and/or control the pressure within the system. Class B
105 Cardiopulmonary bypass temperature controller A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger. Class B 106 Cardiopulmonary bypass vascular catheter, cannula, or tubing A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
ardiopulmonary surgery to
cannulate the vessels, perfuse the
coronary arteries, and to interconnect the
catheters and cannulas with an oxygenator.
The device includes accessory bypass
equipment.
Class B
107 Cardiopulmonary
bypass/extracorporeal
membrane oxygen
(ECMO) drainage
cannula (Venous
cannula)
A semi-rigid or rigid tube intended to be
surgically inserted into the right atrium or
large vein to serve as a channel for the
extracorporeal transport of deoxygenated
blood from a patient during
cardiopulmonary bypass and/or
extracorporeal membrane oxygenation; in
some settings it may be referred to as a
venous cannula.
Class D
108 Cardiopulmonary
bypass/extracorporeal
membrane oxygen
(ECMO) return cannula
(Arterial cannula)
A semi-rigid or rigid tube intended to be
surgically inserted into an artery or vein to
serve as a channel for the extracorporeal
transport of oxygenated blood to a patient
during cardiopulmonary bypass and/or
extracorporeal membrane oxygenation.
Class D
109 Cardiopulmonary
parameter spot-check
measurement software
An application software program intended
to be installed on a computer/workstation to
assist a healthcare provider in the spot-
check (user-initiated) measurement of a
cardiovascular and/or pulmonary
parameter(s) [e.g., blood pressure,
electrocardiography (ECG), respiratory
rate, haemoglobin oxygen saturation
(SpO2)]; it might also be intended for
additional physiological measurements
[e.g., electromyography (EMG), galvanic
skin response (GSR)].
(ECG), respiratory rate, haemoglobin oxygen saturation (SpO2)]; it might also be intended for additional physiological measurements [e.g., electromyography (EMG), galvanic skin response (GSR)]. It is intended to display, store, and allow communication of the physiological data, and may include interpretive algorithms to assist diagnosis; it is not intended for continuous bedside/intraoperative monitoring. Class B
110 Cardiopulmonary physiological parameter analysis software A software program intended to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology. Class C 111 Cardiopulmonary resuscitation feedback device A manually-operated device intended to be applied to the chest of a patient experiencing cardiac arrest to assist a person trained in cardiopulmonary resuscitation (CPR) to deliver effective manual chest compressions. It is intended to translate an applied downward force into a chest compression and may also assist the timing of chest compressions.
citation (CPR) to deliver effective
manual chest compressions. It is intended
to translate an applied downward force into
a chest compression and may also assist
the timing of chest compressions.
Class B
112 Cardiopulmonary stress
exercise monitoring
system
An assembly of devices intended to
noninvasively assess the cardiopulmonary
response to exercise or measure of energy
expenditure using indirect calorimetry. The
system typically monitors functions such as
continuous electrocardiogram (ECG), O2
and CO2 levels, etc.
Class B
113 Cardiopulmonary stress
exercise monitoring
system computer
A dedicated computer with a specific
software package installed and intended to
interpret the various physiological
parameters and waveforms generated
during stress exercise testing of a patient
while connected to a stress exercise
monitoring system.
Class B
114 Cardiothoracic implant
introduction kit
A collection of devices intended to assist
the surgical introduction of an implantable
cardiothoracic device (e.g., implantable
cardiac monitor) within a subcutaneous
cavity in the thorax; it is not intended for
implantation within an organ (i.e., heart,
lungs or blood vessels).
Class C
115 Cardiotocography
telemetric monitoring
system
An assembly of devices intended to be
used to continuously measure and
wirelessly transmit foetal heart rate and
uterine contraction signals from a patient to
a cardiotocograph/monitor.
Class C
n assembly of devices intended to be
used to continuously measure and
wirelessly transmit foetal heart rate and
uterine contraction signals from a patient to
a cardiotocograph/monitor.
Class C
116 Cardiotocography
telemetric monitoring
system receiver
A component of a cardiotocography
telemetric monitoring system intended to
receive wireless signals from the
transmitter that senses fetal heart rate and
uterine contractions during labor.
Class B
117 Cardiotocography
telemetric monitoring
system transmitter
A component of a cardiotocography
telemetric monitoring system intended to
continuously measure and wirelessly
transmit foetal heart rate and uterine
contraction signals to the system's receiver.
Class B
118 Cardiotomy reservoir
A device intended to be integrated within
an extracorporeal circuit to collect, store,
and filter blood typically during a
cardiopulmonary bypass procedure; it does
not include additional functional
components such as an oxygenator.
Class C
119 Cardiovascular catheter
A thin, hollow tube called a catheter is
inserted into a large blood vessel that leads
to heart.
Class D
120 Cardiovascular catheter
sheath
A device intended to be used during
cardiovascular catheterization (e.g.,
femoral, pulmonary) to cover and protect
the exposed proximal end of a
cardiovascular catheter to prevent
contamination (extending the sterile field of
the external catheter) and/or to contain a
backflow of blood (e.g., during catheter
introduction, repositioning or removal).
ular catheter to prevent
contamination (extending the sterile field of
the external catheter) and/or to contain a
backflow of blood (e.g., during catheter
introduction, repositioning or removal).
Classs B
121 Cardiovascular
embolization implantation
kit
A collection of dedicated instruments
intended to be used for the implantation of
an embolization implant (implant not
included). (e.g., needle, introducer,
guidewires, catheter).
Class D
122 Cardiovascular implant
implantation tool base
A sterile plate-like device intended to
function as a sturdy support (base) for the
holder/implantation tool of a cardiovascular
implant (e.g., biologic-polymer aorta graft,
heart valve bioprosthesis).
Class A
123 Cardiovascular patch,
animal-derived
An implantable material intended to
reinforce suture lines and/or increase the
strength of weak or injured cardiac and/or
peripheral vascular tissues during
cardiovascular repair/reconstruction
procedures (e.g., annulus or septal defect
repair, endarterectomy, profundaplasty).
Class D
ak or injured cardiac and/or
peripheral vascular tissues during
cardiovascular repair/reconstruction
procedures (e.g., annulus or septal defect
repair, endarterectomy, profundaplasty).
Class D
124 Cardiovascular patch,
synthetic
An implantable material intended to
reinforce suture lines and/or increase the
strength of weak or injured cardiac and/or
peripheral vascular tissues during
cardiovascular repair/reconstruction
procedures (e.g., annulus or septal defect
repair, endarterectomy, profundaplasty).
Class D
125 Cardiovascular prosthetic
devices
An intra-cardiac patch or pledget which is a
medical device placed in the heart and is
used to repair septal defects, for patch
grafting, to repair tissue, and to buttress
sutures.
Class D
126 Cardiovascular
risk/probability
assessment interpretive
software
An interpretive software program intended
to be used in the assessment of
risk/probability for having a cardiovascular
condition (e.g., significant coronary
stenosis) or event (e.g., heart attack,
ischemic stroke, unstable angina, coronary
revascularization).
Class B
127 Cardiovascular-risk
peripheral arterial
tonometry system
An assembly of devices intended to assess
peripheral artery endothelial dysfunction
(poor vasodilatory response) and/or arterial
stiffness through the noninvasive
measurement of arterial pulsatile volume
changes in the fingertip during a reactive
hyperemia test (occlusion of blood flow
followed by abrupt release).
rterial
stiffness through the noninvasive
measurement of arterial pulsatile volume
changes in the fingertip during a reactive
hyperemia test (occlusion of blood flow
followed by abrupt release).
Class B
128 Cardiovascular-risk
peripheral arterial
tonometry system sensor
A pneumo-electronic device, usually
integrated into a cuff-like device intended to
be placed on a patient's finger during a
reactive hyperemia test for the assessment
of endothelial dysfunction (poor
vasodilatory response) and arterial
stiffness.
Class B
129 Carotid artery shunt
It is intended to serve as a temporary blood
conduit (a shunt) connecting the distal
internal carotid artery to the proximal
common carotid artery allowing
intravascular blood to continuously flow to
the patient's brain during an
endarterectomy procedure.
Class D
130 Carotid filter system
Intended to be used while performing
angioplasty and stenting procedures in
carotid arteries.
Class D
131 Carotid sinus nerve
stimulator
A carotid sinus nerve stimulator is an
implantable device used to decrease
arterial pressure by stimulating Hering's
nerve at the carotid sinus.
Class D
s D 131 Carotid sinus nerve stimulator A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus. Class D
132 Catheter guidewire
It is intended to facilitate the placement of
balloon dilatation catheters during
percutaneous angioplasty (PTCA) and
percutaneous transluminal coronary
transluminal angioplasty (PTA). The PTCA
Guide Wires are not to be used in the
cerebral blood vessel.
Class D
133 Central venous catheter
It is indicated for use in patients requiring
administration of solutions, blood sampling,
central venous pressure monitoring and
injection of contrast media.
Class B
134 Central venous catheter
inside-out introduction
set
A collection of invasive devices intended to
enable introduction of a central venous
catheter (CVC) into an occluded vein (e.g.,
subclavian) by creating a puncture site
from the inside of the vein under
fluoroscopic guidance.
Class D
135 Central venous catheter
navigation system,
electrocardiographic
An assembly of devices intended to use
electrocardiographic (ECG) data to assist
guidance and positioning of a central
venous catheter [e.g., peripherally-inserted
central catheter (PICC), central venous
catheter (CVC), haemodialysis catheter].
diographic (ECG) data to assist
guidance and positioning of a central
venous catheter [e.g., peripherally-inserted
central catheter (PICC), central venous
catheter (CVC), haemodialysis catheter].
Class C
136 Central venous catheter
navigation system,
electrocardiographic/mag
netic
An assembly of devices intended to use
electrocardiographic (ECG) and magnetic
data to assist guidance and positioning of a
central venous catheter [e.g., peripherally-
inserted central catheter (PICC)].
Class C
137 Central venous
catheterization kit, long-
term
A collection of devices and materials
intended for the long-term (>30 days)
introduction of a central venous catheter
(CVC) for various infusion/aspiration
procedures (i.e., non-dedicated).
Class D
138 Central venous
catheterization kit, short-
term
A collection of devices and materials
intended for the short-term (<= 30 days)
introduction of a central venous catheter
(CVC) for various infusion/aspiration
procedures (i.e., non-dedicated).
Class D
139 Central/peripheral
venous pressure monitor
A device that measures and records
invasive central or peripheral venous blood
pressure measurements, or the difference
between the central and peripheral venous
pressures of the patient using an indwelling
catheter and a pressure manometer.
Class C
eripheral venous blood pressure measurements, or the difference between the central and peripheral venous pressures of the patient using an indwelling catheter and a pressure manometer. Class C
140 Centrally-inserted central
venous catheter
It is intended to be introduced into a neck
or thoracic vein and often advanced into
the superior vena cava for various
infusion/aspiration procedures (i.e., non-
dedicated) including the intravenous
administration of nutrients, fluids,
chemotherapeutic agents or other drugs,
and blood sampling or delivery; it may also
be used to monitor venous pressure.
Class D
141 Chamber-decompression
cardiac catheter (Cardiac
vent catheter)
It is intended to decompress a heart
chamber, especially left ventricle, by
removing blood, air and/or other debris
during a surgical procedure such as a
cardiopulmonary bypass. It may include a
pressure monitoring line to continuously
measure the pressure of a chamber.
Class D
143 Cholangiography
catheter
Diagnostic evaluation of the bile ducts
during laparoscopic cholecystectomy
procedures.
Class B
144 Cholangiography needle
It is intended to be used to deliver contrast
media to the biliary tract for
cholangiographic procedures. This is a
single-use device.
Class B
145 Coronary angioplasty
balloon catheter, basic
It is intended for percutaneous transluminal
coronary angioplasty (PTCA) to dilate a
stenotic coronary artery by controlled
inflation of a distensible balloon(s) at its
distal tip.
theter, basic
It is intended for percutaneous transluminal
coronary angioplasty (PTCA) to dilate a
stenotic coronary artery by controlled
inflation of a distensible balloon(s) at its
distal tip.
Class D
146 Coronary angioplasty
balloon catheter,
cutting/scoring
It is intended for use in percutaneous
transluminal coronary angioplasty (PTCA)
to dilate a stenotic coronary artery and
increase myocardial perfusion by controlled
inflation of a distensible balloon with
peripheral cutting/scoring elements (e.g.,
microsurgical atherotomes) intended to
remove stenotic material.
Class D
147 Coronary angioplasty
balloon catheter, drug-
coated
It is intended for percutaneous transluminal
coronary angioplasty (PTCA) to dilate an
atherosclerotic stenotic coronary artery by
controlled inflation of a distal distensible
balloon, and to simultaneously release a
drug intended to inhibit restenosis.
Class D
148 Coronary angioplasty
balloon catheter,
perfusing
It is intended for use in percutaneous
transluminal coronary angioplasty (PTCA)
to dilate a stenotic coronary artery by
controlled inflation of a distensible balloon.
Class D
theter, perfusing It is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. Class D
149 Coronary artery clamp A manual surgical instrument intended to directly compress a coronary artery during coronary artery graft surgery to create a temporary atraumatic haemostasis (arrest or prevention of bleeding). Class B 150 Coronary artery exposure retractor A surgical instrument intended to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self- retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. Class B 151 Coronary artery guidewire extension It is intended to provide the necessary length to allow the exchange of one coronary artery dilatation catheter for another, while maintaining the position of the cardiac catheter guidewire in the coronary artery, during angiography or percutaneous transluminal coronary angioplasty (PTCA). Class A 152 Coronary artery infusion catheter It is intended to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery.
nostic
or therapeutic solutions (e.g., angiographic
contrast medium, heparin solution, saline),
and often to function as a passage for a
guidewire to assist its placement in the
coronary artery.
Class D
153 Coronary artery occluder
A device used to temporarily ligate and fix
the coronary artery using a snare during
the off-pump coronary artery bypass
grafting (CABG).
Class D
154 Coronary artery
perfusion catheter
It is intended to perfuse the coronary
arteries with shunted blood (e.g., from a
femoral artery) to prevent ischemia typically
during off-pump coronary artery bypass
grafting or during minimally-invasive
cardiac surgical procedures.
Class D
155 Coronary dilatation
catheter
It is intended for balloon dilatation of a
hemodynamically significant coronary
artery or bypass graft stenosis in patients
evidencing coronary ischemia for the
purpose of improving myocardial perfusion.
Class D
156 Coronary sinus cannula
It is intended to be surgically inserted,
temporarily, into the ostium of the coronary
sinus to provide retrograde coronary
perfusion/cardioplegia during
cardiopulmonary bypass or minimally
invasive surgery.
Class D
157 Coronary sinus
venogram catheter
It is intended for use within the coronary
sinus to infuse contrast medium solution
into the coronary vasculature for venogram
imaging procedures.
Class D
157 Coronary sinus venogram catheter It is intended for use within the coronary sinus to infuse contrast medium solution into the coronary vasculature for venogram imaging procedures. Class D
158 Coronary venous pacing
lead
It is a flexible device intended to serve as
an electrical conductor to transmit pacing
impulses from an implanted cardiac
resynchronization therapy (CRT) pulse
generator to the left ventricle of the heart.
Class D
159 Coronary venous pacing
lead
An MR conditional implantable device
intended to serve as an electrical conductor
to transmit pacing impulses from an
implanted cardiac resynchronization
therapy (CRT) pulse generator to the left
ventricle of the heart. It may also transmit
electrical responses from the heart back to
the pacemaker; it is not intended to
conduct defibrillation impulses.
Class D
160 Counterpressure
sphygmomanometer
An automatic electronic
sphygmomanometer intended to
noninvasively measure blood pressure
using a self-contained software program
that regulates automatic finger-cuff inflation
and measurement cycles. that measures
the change in blood volume taking place in
a single finger.
Class B
161 Doppler blood-flow
measurement
ultrasound system
A portable or stationary ultrasonic device
that does not produce 2-dimensional or 3-
dimensional images, and is intended to be
used for determining various blood-flow
related parameters of the heart, artery, or
vein.
ary ultrasonic device that does not produce 2-dimensional or 3- dimensional images, and is intended to be used for determining various blood-flow related parameters of the heart, artery, or vein. Class C 162 Drug-coated-metal coronary artery stent A non-bioabsorbable device coated with a drug, intended to be implanted via a delivery catheter into a coronary artery (or saphenous vein graft) to maintain its patency. Class D 163 Drug-eluting coronary artery stent, antibody- coated It is intended to be implanted via a delivery catheter into a coronary artery (or saphenous vein graft) to maintain its patency. Class D 164 Drug-eluting coronary artery stent, bioabsorbable-polymer- coated A non-bioabsorbable device covered with a bioabsorbable polymer that contains a drug, intended to be implanted via a delivery catheter into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. Class D 165 Drug-eluting coronary artery stent, fully- bioabsorbable A bioabsorbable device with a drug coating intended to be implanted, via a delivery catheter, into a de novo or restenotic native coronary artery during a percutaneous coronary intervention (PCI) to temporarily maintain its patency, typically in patients with symptomatic atherosclerotic heart disease. Class D
otic native coronary artery during a percutaneous coronary intervention (PCI) to temporarily maintain its patency, typically in patients with symptomatic atherosclerotic heart disease. Class D
166 Drug-eluting coronary
artery stent, non-
bioabsorbable-polymer-
coated
A non-bioabsorbable device covered with a
non-bioabsorbable polymer and a drug
coating, that is intended to be implanted,
via a delivery catheter, into a coronary
artery (or saphenous vein graft) to maintain
its patency typically in a patient with
symptomatic atherosclerotic heart disease.
Class D
167 Dual-chamber automatic
implantable defibrillator
An implantable pulse generator with a
cardiac rhythm recognition system intended
to collect and analyse electrocardiogram
(ECG) data and deliver appropriate
electrical impulses to defibrillate the heart
(restore normal rhythm) or slow a rapid
heart rate, and to pace the heart (to treat
bradycardia). It is commonly known as an
automatic implantable cardioverter-
defibrillator (AICD).
Class D
168 Dual-chamber
implantable pacemaker,
demand
A battery-powered, implantable device
consisting of a hermetically-sealed pulse
generator with dual chamber pacing leads
and intended to generate and conduct
electrical impulses to the heart typically
when the heart beats too slowly
(bradycardia) or has other abnormal
rhythms (arrhythmias). It provides a
stimulus only when electrical activity within
the heart is sensed to be abnormal
(demand); it is not intended for defibrillation
therapy.
has other abnormal rhythms (arrhythmias). It provides a stimulus only when electrical activity within the heart is sensed to be abnormal (demand); it is not intended for defibrillation therapy. Class D 169 Dual-chamber implantable pacemaker, rate-responsive It is a battery-powered, implantable pulse generator with dual chamber pacing leads, intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. Class D 170 Dual-chamber pacemaker, rate- responsive It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It is not intended for defibrillation therapy. It may be MR conditional. Class D 171 Echocardiograph An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. Class B
D 171 Echocardiograph An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners. Class B
172 Electrocardiograph,
home-use
A device intended to be used by a
layperson in the home to acquire and
process the electrical activity of the heart
for digital display in the form of a graph, to
assist a physician in assessing electrical
cardiac physiology [electrocardiography
(ECG)].
Class B
173 Electrocardiograph,
professional,
multichannel
A device intended to be used by a
healthcare professional in a clinical setting
to acquire and process the electrical
activity of the heart for digital display in the
form of a graph, to assist a physician in
assessing electrical cardiac physiology
[electrocardiography (ECG)]. It is designed
for recording the electrical signal from two
or more configurations of electrodes (ECG-
leads) at a time (multichannel) and may be
intended for resting ECG and/or
stress/exercise ECG.
Class B
174 Electrocardiograph,
professional, single-
channel
A device intended to be used by a
healthcare professional in a clinical setting
to acquire and process the electrical
activity of the heart for digital display in the
form of a graph, to assist a physician in
assessing electrical cardiac physiology
[electrocardiography (ECG)]. It is designed
for recording the electrical signal from only
one configuration of electrodes (ECG-
leads) at a time (single-channel).
ing electrical cardiac physiology
[electrocardiography (ECG)]. It is designed
for recording the electrical signal from only
one configuration of electrodes (ECG-
leads) at a time (single-channel).
Class B
175 Electrocardiographic
ambulatory recorder
(Long term/Holter ECG
recorder)
It is intended to be worn by a patient during
daily activities for 24-hour recording of the
electrocardiographic signals of the heart,
for the diagnosis of cardiac disorders (e.g.,
arrhythmias).
Class B
176 Electrocardiographic
electrode,
reusable/single-use
A noninvasive electrical conductor intended
to conduct electrical signals, generated by
a patient's heart, from the skin surface to
an electrocardiograph (ECG) monitoring
device, via an ECG lead wire (not
included).
Class B
177 Electrocardiographic
lead/catheter adaptor
It is intended to enable a mechanical union
between an in situ cardiac catheter [e.g.,
an electrophysiology (EP) diagnostic
catheter] and an electrocardiograph (ECG)
cable/lead for transmission of heart signals
to an ECG machine, that may otherwise be
incompatible.
Class A
.g.,
an electrophysiology (EP) diagnostic
catheter] and an electrocardiograph (ECG)
cable/lead for transmission of heart signals
to an ECG machine, that may otherwise be
incompatible.
Class A
178 Electrocardiographic
long-term ambulatory
recording analyser
An electronic device intended to be used
for the analysis of long-term (often 24-
hours) heart activity data, which has
previously been registered by an
electrocardiographic long-term ambulatory
recorder (Holter), to which the patient was
connected and carried upon his or her
person.
Class B
179 Electrocardiographic
monitor
A patient bedside device intended to
continuously detect, measure, and display
a patient's electrocardiogram (ECG)
through leads and sensors attached to the
patient; it also typically displays heart rate.
Class B
180 Electrocardiographic
recording paper
A device prepared from a thin sheet of
fibrous material, typically with preprinted
graphics and intended for recording the
output of an electrocardiograph (ECG), or
other device, in the form of measured
physiologic parameters as an
electrocardiogram (ECG).
Class A
181 Electrocardiographic
signal amplifier
An electrical device intended to amplify the
signal level and provide impedance
matching between two or more medical
devices when bioelectrical signals from the
heart are transmitted between them.
n electrical device intended to amplify the
signal level and provide impedance
matching between two or more medical
devices when bioelectrical signals from the
heart are transmitted between them.
Class B
182 Electrocardiography
monitoring system
receiver
A component of an electrocardiograpy
telemetric monitoring system intended to
wirelessly receive, consolidate, and display
electrocardiographic (ECG) signals
[sometimes with an additional parameter
such as haemoglobin oxygen saturation
(SpO2)] from a transmitter connected to a
patient, typically ambulatory, for viewing at
a receiving location (e.g., central station,
bedside monitor).
Class B
183 Electrocardiography
telemetric monitoring
system
An assembly of devices intended to
continuously measure and wirelessly
transmit electrocardiographic (ECG)
signals from a patient to a receiving
location (e.g., central station, bedside
monitor) for viewing.
Class B
184 Electrocardiography
telemetric monitoring
system transmitter
A body-worn component of an
electrocardiography telemetric monitoring
system intended to continuously measure
and wirelessly transmit real-time
electrocardiographic (ECG) signals [and
sometimes additional parameters such as
heart rate, skin temperature, or
haemoglobin oxygen saturation (SpO2)] to
a remote receiver (e.g., central station
server); it may in addition record/analyse
data during a period of time for later
retrieval (Holter reporting).
Class B
in oxygen saturation (SpO2)] to
a remote receiver (e.g., central station
server); it may in addition record/analyse
data during a period of time for later
retrieval (Holter reporting).
Class B
185 Electrode recording
probe, Electrode
recording catheter
A cardiac catheter containing one or more
electrodes; it may be used to pace the
heart or to deliver high energy shocks.
Class D
186 Electromagnetic blood
flowmeter
A device that provides confirmation and
measurement of the blood flow velocity
after coronary artery bypass surgery, organ
transplantation and other forms of
revascularization.
Class B
187 Electronic
sphygmomanometer,
home use
An electronic device intended to be used in
indirect (noninvasive) measurement of
blood pressure. The device is intended for
self-measurement of blood pressure at
home under a physician's supervision, for
the purpose of self-management of blood
pressure by the user.
Class B
188 Electrosurgical cardiac
ablation
electrode/catheter
It is a component of an electrosurgical
assembly intended to deliver
electrosurgical current in a monopolar
configuration (i.e., used with a patient
contact return electrode) to tissues for
cutting/coagulation/ablation during
endoscopic (e.g., laparoscopic,
arthroscopic) surgery.
Class D
189 Embolic filter system
It is indicated for general use as a
guidewire and embolic protection system
during angioplasty and stenting procedures
in carotid arteries with reference vessel
diameters of 2.5 to 5.5 mm.
stem It is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5 mm. Class B 190 Endocardial/interventricul ar septal pacing lead It is intended for pacing and sensing in the right atrium or right ventricle. It may also be intended for pacing and sensing at the bundle of His or in the left bundle branch area as an alternative to right ventricular pacing in a single or dual chamber pacing system. It may be MR conditional. Class D 191 Endomyocardial biopsy device An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart. Class D
192 Epicardial pacing lead This implantable device is intended to transmit pacing impulses from an implanted pacemaker to the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is normally implanted in the outer surface of the heart (epicardium) in close contact to the wall of one of the chambers of the heart (endocardium). It may also be impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation. Class D 193 Epicardial pacing lead inserter A manually-powered, mechanical surgical instrument intended for the implantation of a pacing lead in the epicardium.
tissues to reduce inflammation.
Class D
193 Epicardial pacing lead
inserter
A manually-powered, mechanical surgical
instrument intended for the implantation of
a pacing lead in the epicardium.
Class C
194 External cardiac
compressor
An external cardiac compressor is an
externally applied prescription device that
is electrically, pneumatically, or manually
powered and is used to compress the chest
periodically in the region of the heart to
provide blood flow during cardiac arrest.
External cardiac compressor devices are
used as an adjunct to manual
cardiopulmonary resuscitation (CPR) when
effective manual CPR is not possible (e.g.,
during patient transport or extended CPR
when fatigue may prohibit the delivery of
effective/consistent compressions to the
victim, or when insufficient EMS personnel
are available to
provide effective CPR).
Class B
195 External defibrillator
tester
An electronic instrument used to test an
external defibrillator to ensure compliance
with performance specifications by
connecting to the output of the defibrillator
and measuring the energy delivered by the
defibrillator; it may also perform
transcutaneous pacemaker testing, provide
waveform information, and execute other
quality control procedures.
Class C
196 External pacemaker
analyzer
An electronic instrument designed to test
an external pacemaker to ensure
compliance with performance specifications
by testing any or all of the pulse generator's
parameters including pulse duration, pulse
amplitude, pulse rate, and sensing
threshold.
Class C
sure
compliance with performance specifications
by testing any or all of the pulse generator's
parameters including pulse duration, pulse
amplitude, pulse rate, and sensing
threshold.
Class C
197 External pacemaker, epicardial pacing An external pulse generator (EPG) intended to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used:
- in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. Class D 198 External pacemaker, transcutaneous pacing An external pulse generator (EPG) intended to generate electrical cardiac pacing impulses to stimulate the entire heart simultaneously to resuscitate the patient, restore normal cardiac rhythm, and/or temporarily pace the heart during invasive procedures that may induce cardiac arrhythmias or asystole (cardiac standstill). Class C 199 External pacemaker, transoesophagal pacing A device intended to generate electrical cardiac pacing impulses from an external pulse generator (EPG), located outside the body, and transmit them to the heart via its leads that are placed in the oesophagus. The device is used for temporary stimulation of the heart.
ternal
pulse generator (EPG), located outside the
body, and transmit them to the heart via its
leads that are placed in the oesophagus.
The device is used for temporary
stimulation of the heart.
Class C
200 Extracorporeal circuit
and accessories for long-
term
respiratory/cardiopulmon
ary failure
An extracorporeal circuit and accessories
for long-term respiratory/cardiopulmonary
support (>6 hours) is a system of devices
and accessories that provides assisted
extracorporeal circulation and physiologic
gas exchange of the patient's blood in
patients with acute respiratory failure or
acute cardiopulmonary failure, where other
available treatment options have failed, and
continued clinical deterioration is expected
or the risk of death is imminent. The main
devices and accessories of the system
include, but are not limited to, the console
(hardware), software, and disposables,
including, but not limited to, an oxygenator,
blood pump, heat exchanger, cannulae,
tubing, filters, and other accessories (e.g.,
monitors,
detectors, sensors, connectors).
Class C
201 Extracorporeal
membrane oxygenator
A device designed for the extracorporeal
diffusion of oxygen into blood across a gas-
permeable membrane during a
cardiopulmonary bypass or extracorporeal
membrane oxygenation procedure.
Class C
device designed for the extracorporeal
diffusion of oxygen into blood across a gas-
permeable membrane during a
cardiopulmonary bypass or extracorporeal
membrane oxygenation procedure.
Class C
202 Femoral artery catheter introduction/wound closure set A collection of invasive devices intended to:
- provide percutaneous femoral artery access to enable introduction of a catheter (not included) into the vascular system; and
- plug the femoral artery puncture site
following catheterization to provide
haemostasis.
Class D
203 Femoral artery closure
plug/patch, collagen
An implantable, bioabsorbable device
intended for haemostasis/closure of a
puncture site, through
pressure/compression, on a patient having
undergone femoral artery catheterization.
Class D
204 Femoral artery closure
plug/patch, synthetic
polymer
An implantable, bioabsorbable device
intended for haemostasis/closure of a
puncture site, through
pressure/compression, on a patient having
undergone femoral artery catheterization.
Class D
205 Fetal heart
phonodetector
A device that detects fetal heart sounds
sonically, utilizing ECG with a function to
capture heart sounds.
Class B
206 Flow directed catheter
Used for venous sampling and pressure monitoring. Class B 207 Foetal cardiac monitor A device intended to detect, measure, and display foetal heart activity during the perinatal period.
heter
Used for venous sampling and pressure
monitoring.
Class B
207 Foetal cardiac monitor
A device intended to detect, measure, and
display foetal heart activity during the
perinatal period.
Class C
208 Heart donor-organ
preservation/transport
perfusion set
A collection of devices intended to support
and provide continuous physiologic organ
perfusion to a donated heart during its
preservation, evaluation, and transport in a
heart donor-organ preservation/transport
system from the donor to the receiver
hospital where the organ will be
transplanted into the recipient. It typically
includes a blood/fluid perfusion circuit,
reservoir, pump, oxygenator, warmer,
electrocardiograph and defibrillator leads,
flow/pressure sensors, access and control
valves, cannulae/connectors/tools to
connect the appropriate vessels of the
heart and tubing lines, filters and bags to
add/remove blood and solutions.
Class C
209 Heart donor-organ
preservation/transport
system (control console
included)
This system is intended to support and
maintain a donated heart organ during
transport from the donor to the receiver
hospital where the organ will be
transplanted into the recipient. This system
will provide technical support functions to
keep the organ in as near-physiologic state
as possible.
Class C
eiver hospital where the organ will be transplanted into the recipient. This system will provide technical support functions to keep the organ in as near-physiologic state as possible. Class C
210 Heart valve annulus
sizer, reusable/single-
use
A manual surgical instrument intended to
be used during heart valve repair or
replacement that enables evaluation of the
valve opening (patent annulus) into which
the appropriately sized annuloplasty ring or
replacement valve will be implanted.
Class B
211 Heart valve clip
An implantable device intended for the
reconstruction of an insufficient mitral
and/or tricuspid heart valve and reduction
of valve regurgitation through the fixed
approximation of the valve leaflets.
Disposable devices associated with
implantation (e.g., clip delivery system and
accessories) may be included. Recheck??
Class D
212 Heart valve prosthesis
holder
A surgical instrument intended to hold a
cardiac (heart) valve prosthesis or a
cardiac annuloplasty ring at, or in proximity
to, its site of implantation during surgery. It
includes an implant mounting/containing
feature and a handle; implantable devices
are not included.
Class A
213 Heart valve prosthesis
tester, single-use
A pen-like device intended to be used to
manually manipulate a heart valve
prosthesis to perform an assessment of the
valvular prosthesis (e.g., its ability to open
and close) prior to implantation and/or
when in situ.
Class C
214 Heart-lung bypass unit
tube
A tube will be placed in your heart to drain
blood to the machine.
esis (e.g., its ability to open
and close) prior to implantation and/or
when in situ.
Class C
214 Heart-lung bypass unit
tube
A tube will be placed in your heart to drain
blood to the machine.
Class C
215 Hemoconcentrator set
A hemoconcentrator is a fluid removal
device used during cardio bypass surgery.
The device is inserted into the extracorpeal
circuit where it acts to control hemodilution,
maintain hematocrit levels and reduce the
need for additional blood products during
and after surgery.
Class D
216 His bundle detector
A device intended to detect disorders of
impulse conduction in the bundle of His
(atrioventricular) from the atrium to the
cardiac ventricle.
Class C
217 Impedance cardiac
output unit (Impedance
cardiography)
A device intended to quantify cardiac
output from measurements of the thoracic
impedance changes associated with
cardiac activity.
Class B
218 Impedance cardiograph
An electrocardiograph used to record
variations in chest electric impedance
generated by myocardial activity.
Class B
ges associated with
cardiac activity.
Class B
218 Impedance cardiograph
An electrocardiograph used to record
variations in chest electric impedance
generated by myocardial activity.
Class B
219 Implantable cardiac
device management
application software
An application software program intended
to be used in the management of an
implantable cardiac device (e.g., monitor,
pulse generator, pacemaker, defibrillator)
by enabling computer-assisted functionality
typically in one or more of the following
areas: device programming; device
function analysis; data extraction, storage,
analysis and/or transfer; and clinical
consultation/intervention planning.
Class D
220 Implantable cardiac
monitor
A device intended to be implanted to
monitor, record, and store
electrocardiographic signals to help
diagnose and monitor cardiac arrhythmias
and/or acute coronary syndrome (ACS)
changes.
Class D
221 Implantable cardiac
monitor (ICM)
programmer/transmitter/
alarm
A device designed to be operated by a
clinician or patient to non-invasively change
the settings (e.g., turn on/off) of an
implantable cardiac monitor (ICM), and/or
extract data from the implant, and/or
provide an alarm function; it is not intended
to communicate with a therapeutic cardiac
implant.
urn on/off) of an
implantable cardiac monitor (ICM), and/or
extract data from the implant, and/or
provide an alarm function; it is not intended
to communicate with a therapeutic cardiac
implant.
Class D
222 Implantable pacemaker
analyzer, intraoperative
An electronic instrument intended to test an
implanted cardiac pacemaker, including the
lead/tissue interface at the time of
implantation, for invasive pacemaker
evaluation and/or during electrophysiology
(EP) diagnostic procedures.
Class C
223 Implantable pulse
generator mesh bag,
bioabsorbable
An implantable woven/knitted or porous
bag made from a bioabsorbable synthetic
polymer(s) intended to envelop an
implantable pulse generator (IPG) (e.g.,
cardiac pacemaker/defibrillator,
neurostimulator) to stabilize the implant in
the subcutaneous pocket in which it is
implanted.
Class D
224 Implantable pulse
generator mesh bag,
non-bioabsorbable
An implantable woven/knitted or porous
bag made from a non-bioabsorbable
synthetic polymer(s) intended to envelop
an implantable pulse generator (IPG) (e.g.,
cardiac pacemaker/defibrillator) to stabilize
the implant in the subcutaneous pocket in
which it is implanted; it does not contain an
antimicrobial agent.
Class D
225 Implantable vascular
closure clip
A non-bioabsorbable metallic clip intended
to be implanted following a percutaneous
catheterization procedure to close the
punctured access site on an artery
(typically femoral) and improve
haemostasis.
Class D
e metallic clip intended to be implanted following a percutaneous catheterization procedure to close the punctured access site on an artery (typically femoral) and improve haemostasis. Class D
226 Implanted subcutaneous
intravascular port and
catheter
The device allows for repeated access to
the vascular system for the infusion of
fluids and medications and the sampling of
blood.
Class C
227 Intra-aortic balloon
An intra-aortic balloon is a prescription
device that consists of an inflatable balloon,
which is placed in the aorta to improve
cardiovascular functioning during certain
life-threatening emergencies, and a control
system for regulating the inflation and
deflation of the balloon.
Class C
228 Intra-aortic balloon
control system (balloon
pump)
An intra-aortic balloon control system,
which monitors and is synchronized with
the electrocardiogram, provides a means
for setting the inflation and deflation of the
balloon with the cardiac cycle.
Class B
229 Intra-aortic system
balloon and control
It is a mechanical device that increases
myocardial oxygen perfusion while at the
same time increasing cardiac output.
Class B
230 Intracardiac catheter-tip
electrode
An electrode located at one end of an
appropriate flexible catheter (not included)
intended to be inserted into the chambers
of the heart to detect the presence of
certain indicators to measure cardiac
output. It may also be used to characterize
the electrical activity of the heart.
ded to be inserted into the chambers of the heart to detect the presence of certain indicators to measure cardiac output. It may also be used to characterize the electrical activity of the heart. Class D 231 Intracardiac circulatory assist axial-pump catheter (intracardiac pump) A device with a built-in electrically-powered axial flow pump, inended to provide circulatory assistance to the heart by pumping blood during heart failure. It is typically used emergently post acute myocardial infarction (AMI), electively for high-risk cardiac catheterization, for open chest surgery, and/or during transport between hospitals. Class D 232 Intracardiac circulatory assist axial-pump catheter control unit A device intended to operate and monitor an intracardiac circulatory assist axial- pump catheter (e.g., a catheter with integrated micro motor and impeller) to provide circulatory assistance to the heart by pumping blood during heart failure. It is typically used emergently [e.g., post acute myocardial infarction (AMI)] or electively when haemodynamic support is necessary. Class D 233 Intracardiac oximeter A device that measures the oxygen saturation of blood pumped from the heart to the lungs (SvO2-venous oxygen saturation). Class C
namic support is necessary. Class D 233 Intracardiac oximeter A device that measures the oxygen saturation of blood pumped from the heart to the lungs (SvO2-venous oxygen saturation). Class C
234 Intracardiac pacemaker
A hermetically-sealed pulse generator that
may be impregnated with a steroid (e.g.,
dexamethasone) and intended to be
implanted with a catheter, via transvenous
access, into the right ventricle (i.e., single-
chamber pacing) of an arrhythmic heart to
generate/conduct electrical impulses to
improve cardiac output.
Class D
235 Intracardiac pacemaker
extraction catheter
It is a steerable device intended to be
introduced into the right ventricle of the
heart to remove an implanted intracardiac
pacemaker; it may also be used to remove
an intracardiac pacemaker that has
migrated to the peripheral vasculature.
Class D
236 Intracardiac pacemaker
programming interface
unit
An external device intended to interface a
dedicated patient lead (cable with skin
surface electrodes) with a pacemaker
programmer (from which it draws its
power), to enable noninvasive interrogation
and programming of an implanted
intracardiac pacemaker using high
frequency electrical pulses (as an
alternative to wireless communication); it is
also intended to collect electrocardiogram
(ECG) data for observation of pacemaker
function.
pacemaker using high
frequency electrical pulses (as an
alternative to wireless communication); it is
also intended to collect electrocardiogram
(ECG) data for observation of pacemaker
function.
Class D
237 Intracardiac ultrasound
imaging catheter,
steerable
A steerable device intended for intracardiac
echocardiography to enable intracardiac
and possibly great vessel (e.g., pulmonary
artery) visualization for the assessment of
cardiac anatomy and physiology, and
visualization of other devices in the heart; it
is not intended for peripheral vascular or
coronary artery insertion/imaging.
Class D
238 Intraluminal artery
stripper
An intraluminal artery stripper is a device
used to perform an endarterectomy
(removal of plaque deposits from
arterisclerotic arteries.)
Class D
239 Intravascular
anastomosis
occluder/vascular plug
A device designed to temporarily occlude
the flow of blood in the lumen of a blood
vessel at a vascular anastomosis, primarily
to control bleeding and enable operative
field visualization during peripheral
vascular bypass grafting and vessel repair
surgery.
Class D
240 Intravascular diagnostic
catheter
Used to record intracardiac pressures, to
sample blood, and to introduce substances
into the heart and vessels.
Class D
241 Intravascular extraction
catheter-snare
A flexible device intended to be introduced
into a blood vessel or similar structure to
manually retrieve or manipulate a foreign
body.
Class C
s D 241 Intravascular extraction catheter-snare A flexible device intended to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. Class C
242 Intravascular lithotripsy
system balloon catheter,
coronary
An electrically-powered device intended to
be introduced into a coronary artery
stiffened by a highly calcified atheromatous
plaque, to transmit ultrasound (US) waves
[e.g., acoustic pressure pulses] for the
disruption of the plaque to improve vessel
compliance.
Class D
243 Intravascular occluding
catheter
It is a catheter with an inflatable or
detachable balloon tip that is used to block
a blood vessel, to treat malformations, e.g.,
aneurysms of intracranial blood vessels.
Class D
244 Intravenous catheter
A catheter that is inserted into a vein for
supplying medications or nutrients directly
into the bloodstream or for diagnostic
purposes such as studying blood pressure.
Class C
245 Introducer sheath
Intended to provide easier access to the
femoral, popliteal and infrapopliteal
arteries.
Class C
246 Invasive arterial pressure
cardiac output/oximetry
monitor
It is intended to continuously measure and
display arterial pressure cardiac output
(APCO) [minimally-invasive cardiac output
estimation from arterial blood pressure
waveforms] and haemoglobin oxygen
saturation (e.g., SpO2).
Class C
247 Invasive blood pressure
monitor
A device that measures blood pressure
invasively in an artery, and processes and
displays the data.
and haemoglobin oxygen saturation (e.g., SpO2). Class C 247 Invasive blood pressure monitor A device that measures blood pressure invasively in an artery, and processes and displays the data.
248 Laser blood flowmeter
A device that measures blood flow velocity
using laser techniques, noninvasively or
invasively, to identify impairment of blood
flow (e.g., thrombus, stenosis, mechanical
injury), and supports evaluation of the
degree of the impairment.
Class C
249 Laser Sheath
Intended for use as adjuncts to
conventional lead extraction tools in
patients suitable for transvenous removal
of chronically implanted pacing or
defibrillator leads constructed with silicone
or polyurethane outer insulation.
Class C
250 Long-term
sphygmomanometer
data recorder/Telemetric
sphygmomanometer
A device intended to be carried by the
patient to record long-term (24 hours) blood
pressure.
Class B
251 Lymphangiography kit
A collection of devices intended to be used
to inject a contrast medium into lymphatic
vessels for their radiographic visualization.
It typically includes a needle, tubing, and
connectors.
Class C
llection of devices intended to be used
to inject a contrast medium into lymphatic
vessels for their radiographic visualization.
It typically includes a needle, tubing, and
connectors.
Class C
252 Magnetocardiograph
A device that uses superconducting sensor
technology (a SQUID fluxmeter) to
measure noninvasively the weak magnetic
field generated on the surface of the chest
in association with cardiac activity and
analyze the data for diagnostic use.
Class B
253 Manual external
defibrillator
An external pulse generator (EPG)
intended to deliver electrical shocks to
defibrillate the heart (restore normal
rhythm) in a procedure initiated by a
healthcare professional operator who
monitors an electrocardiogram (ECG) to
determine when to treat life-threatening
arrhythmias (ventricular fibrillation and
pulseless ventricular tachycardia) in
sudden cardiac arrest (SCA) patients.
Class C
254 Mechanical atherectomy
system, coronary,
battery/line-powered
An assembly of devices intended to
mechanically disrupt/remove atheroma
plaque from the walls of coronary arteries.
Class D
255 Micro-catheter
It is intended to access the peripheral and
neurovasculature for the controlled
selective infusion of physician-specified
therapeutic agents such as embolization
materials and or
diagnostic materials such as contrast
media.
Class D
256 Mitral annuloplasty ring
A circular band intended to be implanted in
the heart to support a mitral valve annulus
for the reconstruction and/or remodelling of
an insufficient and/or stenotic mitral valve.
nnuloplasty ring A circular band intended to be implanted in the heart to support a mitral valve annulus for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. Class D 257 Mitral bi-leaflet mechanical heart valve prosthesis An artificial substitute for a natural mitral heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. Class D 258 Mitral heart valve bioprosthesis A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. Class D 259 Mitral transcatheter heart valve bioprosthesis An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. Class D 260 Mitral/tricuspid annuloplasty ring, open- surgery A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of Class D
open- surgery A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of Class D
insufficient and/or stenotic mitral or
tricuspid valves.
261 MRI-conditional,
implantable
defibrillator/pacing lead
(Endocardial defibrillation
lead)
An MR-conditional, implantable flexible
wire with an electrode, intended to function
as an electrical conductor to transmit
defibrillation impulses from an implanted
cardioverter-defibrillator (ICD) [automatic
implantable cardioverter-defibrillator
(AICD)] to the endocardium of the right
ventricle. It may also be intended to
transmit pacing impulses from a cardiac
resynchronization therapy (CRT) pulse
generator, AICD, or other pacing device.
Class D
262 Multifunction cardiac
electrode, adult/pediatric
A device intended to be applied to an
adult/pediatric patient for automatic or
manual defibrillation, external pacing,
cardioversion, and electrocardiographic
monitoring through transmission of cardiac
bioelectric signals (typically from the
thoracic surface) to devices that
record/process the signals and potentially
return electrical impulses.
Class C
263 Multiple lumen catheter
Intended for monitoring central venous
pressure (CVP), sampling blood, and
simultaneous administration of multiple IV
solutions or drugs.
lectrical impulses.
Class C
263 Multiple lumen catheter
Intended for monitoring central venous
pressure (CVP), sampling blood, and
simultaneous administration of multiple IV
solutions or drugs.
Class B
264 Neonatal
electrocardiographic
electrode
A non-sterile electrical conductor intended
to be applied to a neonatal patient to
transmit electrical signals from the body
surface to a data measuring/display device
(typicaly an electrocardiograph, patient
monitor, or patient monitoring system) to
produce an electrocardiogram (ECG).
Class B
265 Non-central circulatory
angiopolygraph
A device to examine vascular
hemodynamics except in the heart.
Class B
266 Non-indwelling blood
flow transducer
A device intended for measuring blood flow
externally (extravascularly). The device is
used together with a blood flowmeter. The
device may also measure the blood flow
either inside the heart or over the outside of
a blood vessel.
Class C
267 Noninvasive multiple
cardiovascular
measurement unit
This unit is intended for noninvasive
measurement of multiple cardiovascular
parameters [including electrocardiogram
(ECG), phonocardiogram (PCG), carotid
pulse tracing, femoral pulse tracing and
four limb pulse tracing/blood pressure] to
assist in the diagnosis of cardiac and/or
peripheral vascular disease.
Class C
phonocardiogram (PCG), carotid pulse tracing, femoral pulse tracing and four limb pulse tracing/blood pressure] to assist in the diagnosis of cardiac and/or peripheral vascular disease. Class C
268 Oximetry catheters,
Oximetry Paceport
catheter
It is indicated for the assessment of a
patient’s hemodynamic condition through
direct intracardiac and pulmonary artery
pressure monitoring, cardiac output
determination, continuous mixed venous
catheter oxygen saturation monitoring, and
for infusing solutions.
Class D
269 Pacemaker generator
function analyzer
A pacemaker generator function analyzer is
a device that is connected to a pacemaker
pulse generator to test any or all of the
generator's parameters, including pulse
duration, pulse amplitude, pulse rate, and
sensing threshold.
Class C
270 Pacemaker lead adaptor
A pacemaker lead adaptor is a device used
to adapt a pacemaker lead so that it can be
connected to a pacemaker pulse generator
produced by a different manufacturer.
Class C
271 Pacemaker repair or
replacement material
A pacemaker repair or replacement
material is an adhesive, a sealant, a screw,
a crimp, or any other material used to
repair a pacemaker lead or to reconnect a
pacemaker lead to a pacemaker pulse
generator.
Class D
272 Pacing cardiac catheter
A flexible tube equipped with an electrode
on the distal end. The electrode is inserted
into the heart to control the heart rate.
pacemaker pulse
generator.
Class D
272 Pacing cardiac catheter
A flexible tube equipped with an electrode
on the distal end. The electrode is inserted
into the heart to control the heart rate.
Class D
273 Pacing lead extraction
kit, single use/reusable
A collection of devices intended to remove
the electrically-conducting leads of an
implantable pacemaker or an implantable
cardioverter-defibrillator (ICD). It typically
includes stylets, dilating sheaths, snares,
and retrieval baskets.
Class D
274 Pacing lead implantation
adapter/Flushing tool
A sterile device intended to be connected
to one end of a compatible cardiac pacing
lead containing a lumen for over-guidewire
implantation, to enable flushing of the
lumen (typically with heparinized saline)
and aid insertion of a guidewire during
implantation. It is not implantable.
Class C
275 Pacing system analyzer
A pacing system analyzer (PSA) is a
prescription device that combines the
functionality of a pacemaker electrode
function tester and an external pacemaker
pulse generator (EPPG). It is intended to
supply an accurately calibrated, variable
pacing pulse for measuring the patient's
pacing threshold and intracardiac R-wave
potential.
Class C
emaker
pulse generator (EPPG). It is intended to
supply an accurately calibrated, variable
pacing pulse for measuring the patient's
pacing threshold and intracardiac R-wave
potential.
Class C
276 Pacing/defibrillation lead
cap
An implantable device intended to cover
and protect the lead terminals of an
implantable pacing device (e.g., an
implanted pacemaker or defibrillator) during
the implantation procedure, or to isolate
(cap) any lead terminals that are not used.
This device is implanted with the
pacemaker or defibrillator system.
Class D
277 Pacing/defibrillation lead
cap kit
A collection of various implantable pacing
lead caps intended to cover and protect the
lead terminals of an implantable pacing
device (e.g., an implanted pacemaker or
defibrillator) during the implantation
procedure, or to isolate (cap) any lead
terminals that are not used.
Class D
278 Pacing/defibrillation lead
electrical adapter
An implantable device intended to adapt
the electrical connectors of an implanted
pacemaker and/or defibrillator pacing lead
to a non-compatible pacemaker or
defibrillator (i.e., when they do not meet
connection design). This device is
implanted with the pacemaker or
defibrillator system.
Class D
279 Pacing/defibrillation lead
electrical extension
adapter
An implantable device intended to provide
a functional and modified connection
between existing pacing leads (e.g., IS-1
leads) and an implantable
pacing/defibrillation device (e.g.,
pacemaker, defibrillator).
device intended to provide
a functional and modified connection
between existing pacing leads (e.g., IS-1
leads) and an implantable
pacing/defibrillation device (e.g.,
pacemaker, defibrillator). It consist of
extension leads to increase the reach of
the pacing leads.
Class D
280 Pacing/defibrillation lead
extraction expander
A device intended to dilate the end of a cut
implantable pacemaker or implantable
cardioverter-defibrillator (ICD) lead,
typically to enable correction of any
deformities to the lead, allowing for
accurate lead sizing with a gauge in
preparation for lead extraction.
Class A
281 Pacing/defibrillation lead
extraction extender
A device intended to be used during the
release and removal of a cut implantable
pacemaker or implantable cardioverter-
defibrillator (ICD) lead, of the solid type
(lumenless), from surrounding tissue during
lead extraction.
Class A
282 Pacing/defibrillation lead
extraction stylet
It is a lead extraction accessory intended to
be used to debride foreign matter from
inside the lead body and may be used to
measure the length of the lead after
connector has been removed.
Class A
s a lead extraction accessory intended to be used to debride foreign matter from inside the lead body and may be used to measure the length of the lead after connector has been removed. Class A
283 Pacing/defibrillation lead extraction wrap A sterile device intended to be used to aid the release and removal of a cut implantable pacemaker or implantable cardioverter-defibrillator (ICD) lead (hollow coil type) by wrapping around and binding the proximal components of the lead and/or other lead extraction/extension device (e.g., pacing lead stylet). Class A 284 Pacing/defibrillation lead repair kit A collection of sterile tools and materials intended to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items used to repair a pacemaker lead or to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator. Class C 285 Pacing/defibrillation lead repair tool A dedicated device, typically designed as a wrench or a screwdriver, intended to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). It may also be used to reconnect a pacemaker/defibrillator lead to a pacemaker/defibrillator generator.
r
the lead of an implantable pacemaker or an
implantable cardioverter-defibrillator (ICD).
It may also be used to reconnect a
pacemaker/defibrillator lead to a
pacemaker/defibrillator generator.
Class A
286 Pacing/defibrillation lead
setscrew
A sterile device intended to connect and
secure the attached pacing lead terminal(s)
in the connection socket of an implantable
pacing device (e.g., an implanted
pacemaker or defibrillator) during the
implantation procedure.
Class A
287 Pacing/defibrillation lead
stylet
It is intended to be percutaneously inserted
into the coronary venous vasculature to aid
in the transvenous placement and/or
removal of implantable
pacemaker/defibrillator leads; it may in
addition be intended to extract an
indwelling catheter or other foreign object.
Class D
288 Pacing/defibrillation lead
suture sleeve
It is intended to function as a channel for
an implantable electrical stimulation lead
(e.g., pacing lead, defibrillation lead,
neurostimulation lead) to allow the surgeon
to suture the lead to the patient's tissue to
prevent it from moving after the
implantation procedure is completed. It
may be implanted with the electrical
stimulator, pacemaker or defibrillator
system.
Class D
to the patient's tissue to prevent it from moving after the implantation procedure is completed. It may be implanted with the electrical stimulator, pacemaker or defibrillator system. Class D
289 Pacing/defibrillation lead suture tunneller A hand-held manual surgical instrument designed to create a tunnel (an artificial passageway) through subcutaneous tissue for the placement of an implantable extracardiac lead/electrode. It may include an integrated sheath (e.g., split sheath) intended to assist lead placement. Class B 290 Patient monitoring system module, cardiac output It is intended for the measurement of cardiac output (the volume of blood pumped by the heart per minute) obtained through a pressure transducer/catheter introduced into a blood vessel. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). Class C 291 Patient monitoring system module, electrocardiographic A small unit intended for the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device).
ardiogram (ECG) obtained
through cables/leads connected to the
patient. It is designed to operate as part of
a patient monitoring system enhancing the
function of this system (the parent device).
Class B
292 Patient monitoring
system module,
electrocardiographic,
telemetric
This unit is intended for receiving (and
displaying) wireless electrocardiogram
(ECG) signals sent from an ambulatory
patient so that the electrical activity of the
patient's heart can be monitored when the
patient is remote to the patient monitoring
system. It is designed to operate as part of
a patient monitoring system enhancing the
function of this system (the parent device).
Class B
293 Patient monitoring
system module,
electrocardiographic/resp
iratory
This unit is intended for the measurement
of the electrical activity of the heart in the
form of an electrocardiogram (ECG) and to
follow patient respiration patterns to identify
episodes of arrhythmia and/or apnoea also
derived from the ECG. It is designed to
operate as part of a patient monitoring
system enhancing the function of this
system (the parent device).
Class C
294 Percutaneous catheter
A needle catheter getting access to a blood
vessel, followed by the introduction of a
wire through the lumen (pathway) of the
needle.
Class D
295 Percutaneous
intravascular long term
catheter
The device allows for repeated access to
the vascular system for long-term use for
30 days or more, and it is intended for
administration of fluids, medications, and
nutrients; the
sampling of blood, etc.
Class B
r repeated access to the vascular system for long-term use for 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood, etc. Class B
296 Pericardiocentesis
catheter
It is intended for the drainage of effusion
from the pericardial sac (the pericardium).
It may also be used for the
irrigation/instillation of drugs (e.g.,
antibiotics, cytotoxic agents) into the
pericardium.
Class D
297 Pericardiocentesis
needle, reusable
It is intended for the puncture of the
pericardial cavity for the aspiration
(removal) of fluids (pericardiocentesis).
Class D
298 Pericardiocentesis
needle, single-use
It is intended for the puncture of the
pericardial cavity for the aspiration
(removal) of fluids (pericardiocentesis).
Class D
299 Pericardium drainage
catheter
Intended for drainage of the pericardium.
Class D
300 Peripheral angioplasty
balloon catheter, basic
A non-drug-eluting device intended for
percutaneous transluminal angioplasty
(PTA) to dilate a stenotic peripheral (i.e.,
non-cerebral, non-coronary) artery by
controlled inflation of a distensible
balloon(s) at its distal tip; it may also be
intended for positioning and expansion of a
stent/stent-graft.
ral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. Class C 301 Peripheral angioplasty balloon catheter, drug- coated It is intended for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non- coronary) artery by controlled inflation of a distensible balloon(s) at its tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. Class D 302 Peripheral stent system It is intended to be placed in the peripheral arteries that supply blood into body organ. Class D 303 Peripherally-inserted central venous catheter It is intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Class C 304 Phonocardiograph A device that records and detects heart sounds on the body surface using vibrations caused by cardiac activity and transmitted to the body surface via the organs and tissues. Class B
rdiograph A device that records and detects heart sounds on the body surface using vibrations caused by cardiac activity and transmitted to the body surface via the organs and tissues. Class B
305 Phonocardiograph/pulse
wave unit
This device is intended to simultaneously
record the electrocardiogram, combined
with the carotid pulse wave, apex beat,
digital pulse volume, phonocardiogram, etc.
by connecting to the electrocardiograph or
the electrocardiographic analysis system.
Class B
306 Pressure transducer
dome, single
use/reusable
A device (dome) to be connected with a
pressure transducer to form a
measurement system, for invasive blood
pressure measurement or cerebrospinal
fluid pressure measurement. Some types
of device incorporate a stopcock and
flushing device.
Class B
307 Pressure transducer,
single use/reusable
A device used to convert pressure into
electric signals to display on the base unit.
Class B
308 Pulmonary arterial shunt
A small vascular graft used for bypassing a
stenotic pulmonary artery.
Class D
309 Pulmonary heart valve
bioprosthesis
A xenograft (e.g., porcine or bovine heart
valve) intended to be implanted in a patient
during open heart surgery to repair/replace
a dysfunctional pulmonary heart valve, or
to replace a pulmonary valve in patients
undergoing a pulmonary autograft (Ross)
procedure.
ted in a patient
during open heart surgery to repair/replace
a dysfunctional pulmonary heart valve, or
to replace a pulmonary valve in patients
undergoing a pulmonary autograft (Ross)
procedure.
Class D
310 Pulmonary transcatheter
heart valve bioprosthesis
An implantable xenograft (e.g., bovine,
porcine) intended to be used to
repair/replace a stenosed or regurgitant
pulmonary heart valve prosthesis
(previously implanted), or native pulmonary
valve anatomy that may have been
surgically repaired, and which is designed
to be implanted with a catheter via vascular
access.
Class D
311 Retrieval snare
Intended for use in the retrieval and
manipulation of atraumatic foreign bodies
located in the coronary and central
circulatory system and the extracranial
neurovascular anatomy.
Class C
312 Retrieval snare, non
central circulatory
Intended for use in the retrieval and
manipulation of atraumatic foreign bodies
located in the vasculature other than
coronary and central neurovascular
anatomy.
Class D
313 Scalp vein set
Intended to be used for insertion into the
patient's vascular system as an in-dwelling
device to administer fluids intravenously or
to sample blood.
Class C
atomy.
Class D
313 Scalp vein set
Intended to be used for insertion into the
patient's vascular system as an in-dwelling
device to administer fluids intravenously or
to sample blood.
Class C
314 Self-expandable heart
valve bioprosthesis
collapsing tool
A manually-operated device intended to
reduce the diameter of a self-expanding
cardiac valve prosthesis during open
and/or transcatheter cardiovascular surgery
so the collapsed valve can be mounted
onto a dedicated holder or catheter to
facilitate implantation.
Class A
315 Self-expandable heart
valve prosthesis
collapsing tool base
It is to intended to function as a sturdy
support (base) for a self-expanding cardiac
valve prosthesis collapsing tool during the
implantation procedure.
Class A
316 Self-expandable heart
valve prosthesis post-
dilation balloon catheter
It is intended to be used during open
cardiovascular surgery to dilate the inflow
ring of a sutureless cardiac (heart) valve
prosthesis, after its implantation and self
expansion, to facilitate valve sealing and
anchoring.
Class C
317 Semi-automated external
defibrillator, non-
rechargeable/rechargeab
le
This electronic device is intended to
automatically detect cardiac arrhythmias
(ventricular fibrillation/pulseless ventricular
tachycardia) in a sudden cardiac arrest
(SCA) patient, and to audibly/visually
instruct an operator to enable it to activate
defibrillation of the heart or allow the
operator to decide when to activate
defibrillation based on its electrocardiogram
display.
audibly/visually
instruct an operator to enable it to activate
defibrillation of the heart or allow the
operator to decide when to activate
defibrillation based on its electrocardiogram
display.
Class C
318 Single chamber
implantable
Defibrillator/Cardioverter
defibrillator
An implantable pulse generator (IPG) with
a cardiac rhythm recognition system,
intended to deliver an electrical impulse(s)
to defibrillate the heart (restore normal
rhythm) or slow a rapid heart rate, and
typically to pace a slow heart rate. It is
commonly known as an automatic
implantable cardioverter-defibrillator
(AICD). It may be MR conditional.
Class D
319 Single-chamber
implantable defibrillator
An implantable pulse generator (IPG) with
a cardiac rhythm recognition system, to
analyse an electrocardiogram (ECG) with
lead(s) inside or on one heart chamber,
intended to deliver an electrical impulse(s)
to defibrillate the heart (restore normal
rhythm) or slow a rapid heart rate, and
typically to pace a slow heart rate.
Class D
on one heart chamber, intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. Class D
320 Single-chamber implantable pacemaker, fixed rate/demand A battery-powered, implantable device consisting of a hermetically-sealed pulse generator with a single-chamber pacing lead and intended to generate and conduct electrical impulses to the heart typically when the heart beats too slowly (bradycardia) or has other abnormal rhythms (arrhythmias). It may provide constant electrical stimuli to normalize the heartbeat (fixed-rate) and/or provide a stimulus only when electrical activity within the heart is sensed to be abnormal (demand); it is not intended for defibrillation therapy. Class D 321 Single-chamber implantable pacemaker, rate-responsive A battery-powered, implantable device consisting of a hermetically-sealed pulse generator with a single-chamber pacing lead and intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity by sensing changes in the body (e.g., motion, breathing frequency), etc. It is not intended to provide defibrillation therapy.
on to meet the
body's increased need for blood flow due to
activity by sensing changes in the body
(e.g., motion, breathing frequency), etc. It is
not intended to provide defibrillation
therapy.
Class D
322 Single-chamber
pacemaker, rate-
responsive
A device implanted beneath the skin of the
chest with a pacing lead in or on one
chamber of the heart (right atrium or
ventricle) and intended to generate and
conduct electrical impulses to an abnormal
heart to adjust its rate of contraction to
meet the body's increased need for blood
flow due to activity. It is not intended for
defibrillation. It may be MR conditional.
Class D
323 Subclavian catheter
Catheters intended to be placed in veins in
the neck (internal jugular vein), chest
(subclavian vein or auxiliary vein), etc.
Class C
324 Suction ablation catheter
system
Intended for inactivating portions of the
heart's conduction system to prevent
abnormal heartbeat rates, comprising a
tubular body having an open, distal end
and a proximal aperture for applying
suction through the catheter and through
the distal end.
Class C
325 Surgical intravascular
shunt
It is intended to temporarily channel (shunt)
intravascular blood through a vascular
anastomosis, primarily to control bleeding
and enable distal perfusion during coronary
or peripheral vascular bypass grafting and
vessel repair surgery.
Class C
ascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. Class C
326 Surgical microscope fluorescent angiography system A device assembly intended for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. Class B 327 Telemetric electrocardiographic ambulatory recorder (Holter monitor) It is intended to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The device may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover). Class B 328 Temporary cardiac pacing (balloon) catheter It is intended to deliver temporary pacing stimuli to the heart and may detect bioelectric signals from the heart. It is used:
- in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations].
dia or
asystole until a pacemaker can be
implanted to control the heart rate; 2)
during and/or after surgery; or 3) during
cardiac catheterization [e.g.,
electrophysiological (EP) examinations].
Class D
329 Thermal-dilution cardiac
output unit
A unit that is intended to measure the blood
flow from the heart using the indicator
dilution technique, in which a thermal
indicator (e.g., cold saline solution or other
indicator solution) is injected upstream of
the heart and monitored on the
downstream side by a balloon-tipped (flow-
directed) catheter with a temperature
probe.
Class C
330 Thrombectomy catheter
Thrombectomy catheter is specifically
designed to treat deep vein thrombosis
(DVT) in large-diameter upper and lower
peripheral veins.
Class D
331 Transcatheter heart
valve bioprosthesis
implantation catheter
It is intended to be used to deploy and
implant a heart valve bioprosthesis (not
included) during a minimally invasive
transcatheter procedure via transarterial
access (e.g., femoral, subclavian, aortic)
under fluoroscopic guidance.
Class D
332 Transoesophagal pacing
lead
It is intended to regulate cardiac pacing,
with one end connected to an external
temporary pacemaker and the other end
(electrode) applied through the
oesophagus to the heart.
Class C
333 Transtelephonic
implantable pacemaker
analysis system
An assembly of devices designed to
analyse the performance of an implanted
pacemaker based on electrocardiographic
measurements that can be monitored
transtelephonically.
Class C
alysis system An assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. Class C
334 Transthoracic pacing lead It is intended as an electrical conductor between the heart and an external temporary pacing/defibrillation device used to treat postoperative cardiac arrhythmias/cardiac arrests. The electrode end is attached to the myocardium. This device is only used for temporary pacing of the heart. Class C 335 Tricuspid transcatheter heart valve bioprosthesis An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant tricuspid heart valve, or previously-implanted tricuspid heart valve prosthesis, and which is implanted using a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. Class D 336 Ultrasonic blood flowmeter A noninvasive, or invasive ultrasonic Doppler device for blood flow measurement, intended for the identification of various blood flow disorders, e.g., thrombosis. Class C 337 Valve prosthesis rotator A surgical device used during heart valve replacement surgery for changing direction of the flow in an artificial valve. Class C 338 Varicose vein adhesive- treatment kit (Venous adhesive occlusion system) A collection of devices intended to be used for the endovascular closure of the great saphenous vein (GSV) and associated varicosities as a treatment for varicose veins.
esive occlusion
system)
A collection of devices intended to be used
for the endovascular closure of the great
saphenous vein (GSV) and associated
varicosities as a treatment for varicose
veins. It typically includes a surgical
adhesive (e.g., cyanoacrylate), syringe,
delivery catheter, dilator, introducer and a
dispensing gun.
Class D
339 Vascular embolization
device
It is an intravascular implant intended to
control hemorrhaging due to aneurysms,
certain types of tumors.
Class D
340 Vascular graft
extraluminal mesh-
sleeve, coronary
A non-bioabsorbable implantable device
intended to be used for the extraluminal
(external) support of a coronary artery
bypass graft (CABG) [e.g., saphenous vein
graft].
Class D
341 Vascular graft with
bovine-derived valve
A device that combines a bovine-derived
valve with a bovine cervical vein or artificial
blood vessel used for pulmonary artery
replacement (including re-
replacement).Usually intended for
treatment of congenital heart abnormalities.
Class D
342 Vascular irrigation
cannula, cardiac vessel
graft
A device intended to be used during
cardiac surgery to flush an autologous
graft, typically a section of explanted
saphenous vein, to test its integrity and the
closure of lateral vessels, as well as to
remove debris and clots after resection.
Class B
h an autologous
graft, typically a section of explanted
saphenous vein, to test its integrity and the
closure of lateral vessels, as well as to
remove debris and clots after resection.
Class B
343 Vascular irrigation cannula, coronary artery, reusable/single-use It is intended to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. Class C 344 Vectorcardiograph An electrocardiograph (ECG) device intended to record a series of changes in the magnitude and direction (vector) of the potential in a complete cardiac cycle. Class B 345 Vectorcardiograph/ECG electrode It is intended to be applied to the surface of the body to transmit the electrical signal at the body surface to a recording and monitoring device that produce an electrocardiograph or vectorcardiogram. Class B 346 Vein ablation device It is a non-thermal, minimally-invasive device intended for treating the source of varicose veins, providing patients with an immediate recovery and a return to normal daily routines Class C 347 Vena cava filter extraction/repositioning kit A collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter.
47 Vena cava filter
extraction/repositioning
kit
A collection of sterile devices designed to
perform the percutaneous retrieval or
repositioning of an implanted inferior vena
cava (IVC) filter.
Class D
348 Vena cava filter,
permanent/temporary
A vascular device intended to be
percutaneously implanted in the inferior
vena cava (IVC) to prevent pulmonary
embolism (PE); it can be retrieved before a
threshold period or remain as a permanent
implant after the period.
Class D
349 Ventricular bypass
(assist) device
A ventricular bypass (assist) device is a
device that assists the left or right ventricle
in maintaining circulatory blood flow. The
device is either totally or partially implanted
in the body.
Class D
350 Vessel dilator for
percutaneous
catheterization
A vessel dilator for percutaneous
catheterization is a device which is placed
over the guide wire to enlarge the opening
in the vessel, and which is then removed
before sliding the
catheter over the guide wire.
Class C
351 Wearable neonatal heart
rate meter
An electrically-powered device intended to
detect and display the heart rate of a
neonate, typically within the first few hours
after delivery.
Class B
Name of Category: Neurological
Total No. of Devices: 202
intended to detect and display the heart rate of a neonate, typically within the first few hours after delivery. Class B
Name of Category: Neurological
Total No. of Devices: 202
Category: Neurological S. No. Device name Intended use Risk Class 1 Analgesic PENS system Intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve as relief of chronic neuropathic pain. Class B 2 Analgesic TENS system Intended to reduce the perception of/treat pain by transcutaneous electrical stimulation on peripheral nerves. It is intended to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, etc., and may be used in physical therapy and during labour/delivery. Class B 3 Analytical non- scalp cutaneous lead Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. Class A 4 Analytical non-scalp cutaneous electrode Electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring.
signed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring. Class A 5 Analytical scalp electrode, single use/reusable Intended to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. Class B 6 Analytical scalp lead Intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals during encephalography (EEG). Class B 7 Aneurysm clip An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting. Class D
. Class B 7 Aneurysm clip An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting. Class D
8
Antibiotic impregnated
Hydrocephalous Catheter
It is intended for use in the treatment
of hydrocephalous as a component of
a shunt system when draining or
shunting of cerebrospinal fluid (CSF)
is indicated.
Class D
9
Anti-nausea
transcutaneous electrical
nerve stimulation wristband
An electrically-powered device
intended to be worn on the wrist of a
patient to apply electrical stimuli to the
median nerve through the skin
(transcutaneously), to help relieve the
sensation of nausea caused by
various conditions [e.g., pregnancy
(morning sickness), motion (travel
sickness), chemotherapy].
Class B
10
Antiseizure/psychiatric-
therapy vagus nerve
electrical stimulation
system
Implantable device intended to apply
periodic electrical stimuli to the vagus
nerve to help control seizures and/or
to help treat psychiatric disorder
symptoms (e.g., depression).
Class D
11
Atrial cerebrospinal fluid
catheter
Intended to be implanted as the distal
component of a ventriculoatrial shunt
to channel cerebrospinal fluid (CSF) to
the right atrium where it can be
absorbed into the body.
inal fluid catheter Intended to be implanted as the distal component of a ventriculoatrial shunt to channel cerebrospinal fluid (CSF) to the right atrium where it can be absorbed into the body. Class D 12 Autonomic neuropathy heart rate meter Intended to diagnose autonomic nervous system dysfunction (autonomic neuropathy) Class C 13 Balloon catheter for cranial angioplasty It is intended for angioplasty of intra- and extra-cranial arteries harbouring untreated stenoses, or recurrent stenoses after angioplasty and/or stenting of flow diverter deployment. It may also be used for dilatation of insufficiently adapted stents and flow diverters Class D 14 Balloon for Cerebrovascular Occlusion Balloon used to treat blockage or closing of cerebrovascular occlusion vessels/carotid arteries. Class D 15 Bare-metal intracranial vascular stent Intended to be implanted into the base or parent artery of an intracranial aneurysm to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. Class D 16 Behavioural therapy system Intended in the treatment of obsessive/compulsive behaviour and drug abuse, by applying electrical impulse (aversion therapy). Class C 17 Bladder/bowel-evacuation implantable electrical stimulation system Intended to empty the urinary bladder and/or the bowels by applying electrical stimuli typically to the cone- Class D
s C 17 Bladder/bowel-evacuation implantable electrical stimulation system Intended to empty the urinary bladder and/or the bowels by applying electrical stimuli typically to the cone- Class D
shaped end of the spinal cord (conus
medularis).
18
Block-monitoring peripheral
nerve electrical stimulation
system
An assembly of battery-powered
devices intended to apply electrical
stimuli to a peripheral nerve (e.g., the
ulnar or lower extremity nerve) to
assess the adequacy of
neuromuscular block during surgery,
and its reversal during the recovery
period.
Class C
19
Blood
pressure/neuromuscular
transmission monitoring
cuff extension tubing/cable
A length of pneumatic tubing with an
integrated electrical cable intended to
be connected to the existing
tubing/cable of a blood
pressure/neuromuscular transmission
monitoring cuff (not included) to
increase its length, during combined
intraoperative noninvasive blood
pressure (NIBP) and neuromuscular
transmission (NMT) monitoring. This
is a reusable device.
Class B
20
Brain biopsy procedure kit
A packaged collection of sterile
equipment that includes a disposable
brain biopsy needle and other
supplies intended to be used to
perform a stereotaxic sampling of
brain tissue. This is a single-use
device.
ection of sterile equipment that includes a disposable brain biopsy needle and other supplies intended to be used to perform a stereotaxic sampling of brain tissue. This is a single-use device. Class C 21 Brain injury adjunctive interpretive electroencephalograph assessment aid A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. Class C 22 Brain-responsive electrical stimulation system Intended to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to neurological disorders (e.g., epilepsy). Class D 23 Cardiac-therapy vagus nerve electrical stimulation system Intended to apply periodic stimuli to the vagus nerve as a treatment for cardiac failure. Class D
ders (e.g., epilepsy). Class D 23 Cardiac-therapy vagus nerve electrical stimulation system Intended to apply periodic stimuli to the vagus nerve as a treatment for cardiac failure. Class D
24 Central Nervous System Shunt Catheters including Neurological catheters and other Components It is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system including an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume. Class D 25 Cerebral oximeter A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. Class C 26 Cerebral oximeter sensor, single use A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near- infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. Class C 27 Cerebral perfusion catheter Intended for brain protection during profound hypothermic circulatory arrest during aortic surgery.
turation and/or
venous oxygen saturation in the brain.
Class C
27
Cerebral perfusion catheter Intended for brain protection during
profound hypothermic circulatory
arrest during aortic surgery.
Class D
28
Cerebrospinal fluid
catheter tubing set
A sterile two-way tubing with a
stopcock designed to connect the
proximal end of a cerebrospinal fluid
(CSF) drainage catheter directly to a
drainage bag or an intracranial
pressure monitor via a Luer
connection.
Class A
29
Cerebrospinal fluid
external drainage kit
A collection of sterile devices intended
to be used with an intracerebral or
spinal infusion/drainage catheter (not
included) to collect drained
cerebrospinal fluid (CSF) from the
brain ventricles or from the lumbar
subarachnoid (intrathecal) region as a
means of reducing CSF volume and
intracranial pressure (ICP). It typically
includes devices such as a drip
chamber, drainage bag, tubing set,
catheter connector, stopcock, and
filter.
Class A
30
Cerebrospinal fluid
manometer
Intended to measure the
cerebrospinal fluid (CSF)
pressure/intracranial pressure via
lumbar puncture.
Class C
ter connector, stopcock, and
filter.
Class A
30
Cerebrospinal fluid
manometer
Intended to measure the
cerebrospinal fluid (CSF)
pressure/intracranial pressure via
lumbar puncture.
Class C
31 Cerebrospinal fluid shunt adaptor A sterile device intended to enable connection of a cerebrospinal fluid (CSF) shunt or shunt component (e.g., cerebrospinal fluid catheter) to a syringe during shunt patency checking; it is not intended to be implanted. Class B 32 Cerebrospinal fluid shunt connector An implantable device intended to create a fluid path connection between components of a cerebrospinal fluid (CSF) shunt assembly (e.g., lumbar and/or peritoneal catheters of a ventriculoperitoneal or lumboperitoneal shunt), designed to remove excess cerebrospinal fluid from around the central nervous system especially in the treatment of hydrocephalus. Class D 33 Cerebrospinal fluid shunt valve An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). Class D 34 Cerebrospinal fluid shunt valve programmer Intended to noninvasively modify the operating pressure of a programmable, non-active, implanted cerebrospinal fluid (CSF) shunt valve that is part of a CSF shunt.
fluid shunt valve programmer Intended to noninvasively modify the operating pressure of a programmable, non-active, implanted cerebrospinal fluid (CSF) shunt valve that is part of a CSF shunt. Class C 35 Cochlear nerve function operative test electrode An invasive, hand-held, thin instrument (probe) with a distal electrode intended for preoperative and/or intraoperative delivery of electrical stimulation to the cochlear (auditory) nerve to assess nerve function prior to implantation of a cochlear implant (CI). Class B 36 Coma-arousal vagus nerve system Intended to apply periodic stimuli to the vagus nerve for the purpose of exciting the patient to arousal from a vegetative state (i.e., a deep coma). Class D 37 Cortical electrode/subdural electrode A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. Class D
subdural electrode A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. Class D
38
Cranial bone flap fixation
clip
A sterile, non-bioabsorbable device
intended to be partially implanted
around the perimeter of a replaced
cranial bone flap after a craniotomy to
ensure structural stability during the
healing period. It may also be used for
craniofacial bone fracture fixation.
Class D
39
Cranial bone prosthesis
An implantable device intended to
repair a defect of the cranium or
mandible as prescribed by a
healthcare provider for a specified
patient. The device may be used to
repair defects due to injury, surgical
intervention for tumour removal,
congenital anomaly, or disease, or for
cosmetic/aesthetic purposes.
Class D
40
Cranial bur
Intended to fit into an appropriate
powered handpiece that provides the
rotation allowing the user to excavate
soft or hard skull tissue.
Class B
41
Cranial electrotherapy
stimulator
A cranial electrotherapy stimulator is a
device that applies electrical current to
a patient's head to treat insomnia,
depression, or anxiety
Class D
42
Cranial perforator
Metallic rotary endpiece designed to
cut a hole(s) or a circular section(s) of
the skull vault (calvarium) by attaching
to powered drill/handpiece.
on, or anxiety
Class D
42
Cranial perforator
Metallic rotary endpiece designed to
cut a hole(s) or a circular section(s) of
the skull vault (calvarium) by attaching
to powered drill/handpiece.
Class B
43
Cranial port/reservoir
(Cerebrospinal fluid shunt
port/reservoir)
A sterile, implantable chamber
intended to be connected to an
intracerebral catheter for
infusion/injection of materials (e.g.,
chemotherapeutic agents,
radioisotopes) into the brain (e.g.,
cerebral ventricles, cystic tumours,
tumour cavities); it may also be used
for drainage of cerebrospinal fluid
(CSF) from the ventricles and as part
of a ventriculo-peritoneal/atrial shunt
system.
Class D
44
Cranial resinous
compound
A substance used to reconstitute
cranial bone after neurosurgery (i.e.,
cranioplasty). It may be conformed as
an inert implant in an appropriate
shape (e.g., a plate) needed to repair
the defect of the skull, either using an
intraoperatively cured solid
composition, or a preoperatively
fabricated, porous, custom-made,
implant.
Class D
45
Cranial trephine
Intended as a neurosurgical blade
used to cut/remove circular sections of
the skull vault (calvarium) to provide
access to the interior.
Class B
-made,
implant.
Class D
45
Cranial trephine
Intended as a neurosurgical blade
used to cut/remove circular sections of
the skull vault (calvarium) to provide
access to the interior.
Class B
46 Craniotomy power tool system handpiece Intended to be used to rotate a cranial cutting tool (i.e., a drill bit, bur, trephine or perforator) in order to produce a hole or holes in the skull vault (calvarium). Class C 47 Cryogenic surgical device A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. Class D 48 Cutaneous electrode A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. Class B 49 Deep brain electrical stimulation system Designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders, psychiatric disorders and/or to treat chronic, severe, intractable pain. The pulse generator may be implanted in the sternum. Class D 50 Deep brain electrical stimulation system lead Intended to be implanted in specific areas of the deep brain and used along with deep brain electrical stimulation system. Class C 51 Depth electrode A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.
ctrical stimulation system. Class C 51 Depth electrode A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain. Class D 52 Diagnostic peripheral nerve electrical stimulation system Intended to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It is intended to be used for the stimulation of a peripheral nerve or muscle in nerve conduction studies performed during clinical electrophysiology (EP) assessments. Class C 53 Diagnostic somatosensory tactile stimulation system Intended to be used to apply tactile stimuli to the body (e.g., pneumatic activation of a membrane to the fingers and lips) typically for evoked response procedures to investigate the function and potential disorders of the brain. Class B 54 Diskectomy system, percutaneous, automatic Intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. Class D 55 Dura mater sealant Intended to be applied to sutured dura mater to prevent Class C
d for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. Class D 55 Dura mater sealant Intended to be applied to sutured dura mater to prevent Class C
cerebrospinal fluid (CSF) leakage during healing. 56 Echoencephalograph An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head Class C 57 Ejaculation electrical stimulation system Intended to apply electrical stimuli to the nerves that control ejaculation. Class C 58 Electroconvulsive therapy system Intended to apply strong electrical stimuli to a patient's brain to induce convulsions and loss of consciousness, typically to treat major depression, schizophrenia, or mania. Class D 59 Electroencephalogram (EEG) signal spectrum analyzer An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal. Class B 60 Electroencephalograph An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
60
Electroencephalograph
An electroencephalograph is a device
used to measure and record the
electrical activity of the patient's brain
obtained by placing two or more
electrodes on the head.
Class C
61
Electroencephalograph
electrode/lead tester
An electroencephalograph
electrode/lead tester is a device used
for testing the impedance (resistance
to alternating current) of the electrode
and lead system of an
electroencephalograph to assure that
an adequate contact is made between
the electrode and the skin.
Class B
62
Electroencephalograph
test signal generator
An electroencephalograph test signal
generator is a device used to test or
calibrate an electroencephalograph.
Class B
63
Electroencephalograph
tester
Intended to perform quality control
procedures on an
electroencephalograph (EEG)
machine and/or a sleep recording
machine.
Class A
64
Electroencephalographic
electrode cap
Analytical scalp electrodes
preconfigured within a head- worn
device to use with
electroencephalography (EEG).
Class B
65
Electroencephalographic
long-term ambulatory
recorder
Intended to continuously record
electroencephalographic signals in
ambulatory patients for periods
usually from 24 to 72 hours to assess
a variety of neurological conditions
(e.g., epilepsy) and psychiatric
disorders.
Class B
lectroencephalographic signals in ambulatory patients for periods usually from 24 to 72 hours to assess a variety of neurological conditions (e.g., epilepsy) and psychiatric disorders. Class B
66 Electroencephalographic monitoring system Intended to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function. Alongwith which measuring of other physiological parameters such as electromyogram (EMG), respiration wave forms, blood pressure, ocular motility, and/or haemoglobin oxygen saturation (SpO2) and carbon dioxide (CO2) in relation to EEG. Class C 67 Electromyograph Intended in clinical diagnosis of muscular disorders to evaluate muscle weakness and to determine if the weakness is related to the muscles themselves or a problem with the nerves that supply the muscles. Class B 68 Electromyograph cable/lead, sterile An insulated metal wire(s) intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and electromyography (EMG) monitoring device. Class A 69 Electromyograph electrode catheter Intended to be used to monitor electrical activity in muscles of different target areas (other than the brain and heart), such as urethra, oesophagus, diaphragm, etc.
yograph electrode
catheter
Intended to be used to monitor
electrical activity in muscles of
different target areas (other than the
brain and heart), such as urethra,
oesophagus, diaphragm, etc.
Class C
70
Electromyograph
electrode/Electromyograph
needle electrode
A sterile electrical conducting device
designed to be inserted
percutaneously into muscle or nerve
tissue to detect bioelectrical signal
activity. It is not primarily intended for
nerve stimulation.
Class B
71
Electromyography monitor
An electrically-powered device
designed to continuously measure
electrical signals from a patient’s
skeletal muscle and display/record the
signals as an electromyograph (EMG)
to evaluate brain/nerve function,
typically during a surgical procedure. It
may also include data interpretation
and/or telemetry features.
Class C
72
Electronystagmograph
Intended for detecting the electrical
potential caused by eye movements.
Class B
73
Epicranial brain electrical
stimulation system
Intended to apply weak, pulsed (not
continuous) electrical stimuli from
beneath the scalp to specific areas of
the brain for the treatment of focal
epilepsy.
Class D
trical stimulation system Intended to apply weak, pulsed (not continuous) electrical stimuli from beneath the scalp to specific areas of the brain for the treatment of focal epilepsy. Class D
74 Esthesiometer An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity Class A 75 Evoked-potential graphic recording system An assembly of devices intended for assessing brain and sensory function by recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. Class C 76 Extramuscular diaphragm/phrenic nerve system Intended to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically (using extramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing.
lectrical stimulation of the phrenic nerve, to contract the diaphragm rhythmically (using extramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing. Class D 77 Eye-tracking neurological/brain injury assessment device An electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention- deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). Class B 78 Facial nerve locating system Intended to locate a facial nerve by applying an electrical stimulus. Class B 79 Facial nerve-locating system It is intended to locate a facial nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. It is used during diagnosis and assessment of nerve function, to locate nerves during surgery reducing the chance of accidental injury, and to monitor the progress of nerve regeneration after surgery. Class B
g diagnosis and assessment of nerve function, to locate nerves during surgery reducing the chance of accidental injury, and to monitor the progress of nerve regeneration after surgery. Class B
80 Flexible fibreoptic epiduroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of intractable back and leg pain (e.g., chronic lumbago or sciatica). This device is intended to facilitate and/or perform perfusion or wash in the epidural space, dissect epidural adhesions, or deliver medications. Class C 81 Gait- enhancement system, external Intended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying external electrical simulation. Class B 82 Gait-enhancement system, implantable Intended to improve the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders by applying internal electrical simulation. Class D 83 Home seizure monitoring system Intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings.
body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. Class C 84 Human dura mater Human dura mater is human pachymeninx tissue intended to repair defects in human dura mater Class D 85 Implantable intracerebral cannula A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It may include a stylet/trocar blade. Class D 86 Implantable pulse generator mesh bag, bioabsorbable Intended to envelop an implantable pulse generator (IPG) (e.g., cardiac pacemaker/defibrillator, neurostimulator) to stabilize the implant in the subcutaneous pocket in which it is implanted. Class D 87 Implantable spinal cord system programmer Device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). Class C
mmer Device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). Class C
88
Implanted cerebellar
stimulator
An implanted cerebellar stimulator is a
device used to stimulate electrically a
patient's cerebellar cortex for the
treatment of intractable epilepsy,
spasticity, and some movement
disorders. The stimulator consists of
an implanted receiver with electrodes
that are placed on the patient's
cerebellum and an external transmitter
for transmitting the stimulating pulses
across the patient's skin to the
implanted receiver.
Class D
89
Implanted
diaphragmatic/phrenic
nerve stimulator
An implanted diaphragmatic/phrenic
nerve stimulator is a device that
provides electrical stimulation of a
patient's phrenic nerve to contract the
diaphragm rhythmically and produce
breathing in patients who have
hypoventilation (a state in which an
abnormally low amount of air enters
the lungs) caused by brain stem
disease, high cervical spinal cord
injury, or chronic lung disease.
Class D
90
Implanted intracerebral/sub
cortical stimulator for pain
relief
An implanted intracerebral/subcortical
stimulator for pain relief is a device
that applies electrical current to
subsurface areas of a patient's brain
to treat severe intractable pain.
n
relief
An implanted intracerebral/subcortical
stimulator for pain relief is a device
that applies electrical current to
subsurface areas of a patient's brain
to treat severe intractable pain.
Class D
91
Implanted neuromuscular
stimulator
An implanted neuromuscular
stimulator is a device that
provides electrical stimulation to a
patient's peroneal or femoral nerve to
cause muscles in the leg to contract,
thus improving the gait in a patient
with a paralyzed leg.
Class D
92
Implanted spinal cord
stimulator for bladder
evacuation
An implanted spinal cord stimulator for
bladder evacuation is an electrical
stimulator used to empty the bladder
of a paraplegic patient who has a
complete transection of the spinal
cord and who is unable to empty his
or her bladder by reflex means or by
the intermittent use of catheters.
Class D
93
Intracerebral catheter
cranial-fixation kit
A collection of sterile devices intended
to be used to affix an intracerebral
sensor/infusion/drainage catheter on
the skull of a patient. It includes
cranial screws and screwing tools; it
does not include the intracerebral
catheter, and does not include devices
intended for long-term implantation (>
30 days).
Class D
a patient. It includes
cranial screws and screwing tools; it
does not include the intracerebral
catheter, and does not include devices
intended for long-term implantation (>
30 days).
Class D
94 Intracerebral catheterization drill bit A sterile drilling endpiece intended to be used for drilling the skull of a patient to facilitate the introduction and fixation of an intracerebral sensor/infusion/drainage catheter. It is intended to be attached to a manual or electric drilling device. Class B 95 Intracerebral infusion/drainage catheter, long term (Ventricular catheter) It is intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. Class D 96 Intracerebral infusion/drainage catheter, short term A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP).
cles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). Class D 97 Intracerebral sensor catheter It is intended to be surgically inserted through the skull for access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). Class D 98 Intracerebral trocar blade A hand-held, manual surgical instrument with a sharp, needle-like point intended to be used in conjunction with an intracerebral catheter (e.g., ventricular catheter) to puncture tissue and create a channel to access the brain (e.g., cerebral ventricles, cystic tumours) typically for cerebrospinal fluid (CSF) drainage or infusion of materials (e.g., chemotherapeutic agents). Class B 99 Intracranial catheter holder, sterile It is intended to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may Class B
sterile It is intended to secure an intracranial catheter (e.g., intracerebral sensor catheter, intracerebral infusion/drainage catheter, epidural sensor catheter) to the skin; it may Class B
also be used as a marker for the
planned depth of the catheter
insertion.
100
Intracranial catheter
navigation stylet
It is a guiding stylet which may or may
not be connected to an
electromagnetic (EM) coil to enable
navigated placement and insertion of
ventricular catheters or shunts during
neurosurgery.
Class D
101
Intracranial pressure
monitor device
Intended for intermittent or continuous
measurement and display of
intracranial pressure (ICP). It is used
in conjunction with an invasive
intracranial device.
Class D
102
Intracranial/compartmental-
pressure monitor
calibrator/cable
An electronic device intended to
generate a reference baseline for the
standardization of readings of
intracranial pressure (ICP) and/or
pressure in a muscle compartment,
and to transfer the readings from a
catheter (i.e., intracerebral sensor or
compartmental-pressure catheter) to a
pressure monitor.
Class B
103
Intramuscular
diaphragm/phrenic nerve
system
Intended to provide ventilatory support
to a patient with diaphragm
dysfunction of neuromuscular origin
through electrical stimulation of the
phrenic nerve to contract the
diaphragm rhythmically (using
intramuscular electrodes) and cause
the patient to draw breath in a manner
similar to natural breathing.
electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically (using intramuscular electrodes) and cause the patient to draw breath in a manner similar to natural breathing. Class D 104 Intramuscular diaphragm/phrenic nerve system programmer Intended to change, telemetrically, one or more of the operating parameters (the programs) of an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG). Class C 105 Intranasal cooling system Intended for rapid cooling induction in patients where temperature reduction is clinically indicated (e.g., following a cerebral ischemic event, during cardiac arrest) to help mimimize damage to the brain and heart. Class C 106 Intrathecal infusion pump, implantable A device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs to manage intractable pain and muscle spasms of malignant or nonmalignant origin. Class D
planted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs to manage intractable pain and muscle spasms of malignant or nonmalignant origin. Class D
107
Invasive- detection
physiological
monitor
Intended for continuous or intermittent
measurement, display and/or
recording of several invasively-
detected physiological parameters
[e.g., intracranial pressure (ICP),
compartmental pressure].
Class C
108
Leukotome
Intended to cut brain tissue (i.e.,
cutting white matter, leukotomy).
Class B
109
Lumbar cerebrospinal fluid
drainage catheterization kit
A collection of sterile devices intended
for short-term percutaneous access to
the subarachnoid (intrathecal) or
epidural space of the lumbar spinal
column to drain cerebrospinal fluid
(CSF) as a means of reducing CSF
volume and intracranial pressure
(ICP). It includes a spinal
infusion/drainage catheter and
devices intended for catheter insertion
(e.g. Tuohy needle, suture, guidewire)
and CSF collection (e.g., drip
chamber, drainage bag, tubing set,
filter).
Class D
110
Lumboperitoneal shunt
An implantable device intended to
divert excessive cerebrospinal fluid
(CSF) from the subarachnoid space of
the lumbar spine to the peritoneal
cavity where it can be absorbed into
the body, as a treatment for raised
CSF pressure (e.g., caused by
hydrocephalus).
id
(CSF) from the subarachnoid space of
the lumbar spine to the peritoneal
cavity where it can be absorbed into
the body, as a treatment for raised
CSF pressure (e.g., caused by
hydrocephalus).
Class D
111
Lumboperitoneal shunt
peritoneal catheter
A component of a lumboperitoneal
(LP) shunt intended to channel
cerebrospinal fluid (CSF) to the
peritoneal cavity, where it can be
absorbed into the body, in the
management of elevated intracranial
pressure due to increased CSF
(hydrocephalus).
Class D
112
Lumboperitoneal shunt
spinal catheter
A component of a lumboperitoneal
(LP) shunt intended to channel
cerebrospinal fluid (CSF) from the
subarachnoid space of the lumbar
spine in the management of elevated
intracranial pressure due to increased
CSF (hydrocephalus).
Class D
113
Magnetoencephalography
system
Intended to non-invasively detect,
measure, and display bio- magnetic
signals produced by electrically-active
cortical brain tissue, and that provide
diagnostic information about the
location of the active tissue
responsible for cognitive brain
functions relative to the surrounding
brain anatomy.
Class B
tical brain tissue, and that provide diagnostic information about the location of the active tissue responsible for cognitive brain functions relative to the surrounding brain anatomy. Class B
114 Manual cranial rotary handpiece, single-use A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. This is a single-use device. Class B 115 Manual surgical saw, flexible, single use Intended for cutting bone through a sawing action during neurological or orthopaedic surgery. Class B 116 Meningeal prosthesis Intended to repair the meningeal membrane (meninges). Class D 117 Migraine-therapy peripheral nerve electrical stimulator A portable electrically-powered device intended to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. it may be used in conjunction with a smartphone and may be operated by a patient or healthcare provider in the home and healthcare facility.
to treat or prevent symptoms of
migraine/headaches. it may be used
in conjunction with a smartphone and
may be operated by a patient or
healthcare provider in the home and
healthcare facility.
Class B
118
Nasopharyngeal electrode
A nasopharyngeal electrode is an
electrode which is temporarily placed
in the nasopharyngeal region for the
purpose of recording electrical activity
Class C
119
Needle electrode
A needle electrode is a device which
is placed subcutaneously to stimulate
or to record electrical signals.
Class C
120
Nerve conduction velocity
measurement device
It is intended to measure nerve
conduction time by applying a
stimulus, usually to a patient's
peripheral nerve.
Class C
121
Nerve guide,
bioabsorbable, animal-
derived
Collagen matrix material intended to
be used to create a tunnel through
which a discontinuous peripheral
nerve can regenerate to bridge the
proximal and distal nerve stumps.
Class D
122
Nerve guide,
bioabsorbable, synthetic
Synthetic material intended to be used
to create a tunnel through which a
discontinuous peripheral nerve can
regenerate to bridge the proximal and
distal nerve stumps.
Class D
123
Nerve guide, non-
bioabsorbable
Non-bioabsorbable material intended
to be used to create a tunnel through
which a discontinuous peripheral
nerve can regenerate to bridge the
proximal and distal nerve stumps.
Class D
sorbable Non-bioabsorbable material intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. Class D
124
Nerve location/function
operative test pulse
generator
An electrically-powered unit intended
to produce electrical signals for
preoperative and/or intraoperative
application of electrical stimulation, via
a connected hand-held probe with
distal electrodes (not included), to a
neural tissue site to: 1) locate nerves
during surgery to prevent unintentional
injury; 2) diagnose or assess nerve
function; and/or 3) help determine an
optimal electrical stimulation site prior
to implantation of an active implant
[e.g., cochlear implant (CI), auditory
brainstem implant (ABI)]. It does not
display electromyography (EMG)
readings.
Class C
125
Nerve transcutaneous
ultrasound ablation system
Intended to thermally ablate nerves
using ultrasound to relieve chronic
pain caused by conditions such as
arthritis, bone metastases, sacroilitis,
etc.
Class C
126
Nerve-function monitor
It is intended to continuously assess
the adequacy of the nerve function of
a non-ambulatory patient who requires
monitoring (e.g., as a result of trauma,
anaesthesia, intervention, evaluation).
It typically monitors evoked potential
(EP), electromyography (EMG),
electroencephalography (EEG) and/or
neuromuscular block response.
a result of trauma,
anaesthesia, intervention, evaluation).
It typically monitors evoked potential
(EP), electromyography (EMG),
electroencephalography (EEG) and/or
neuromuscular block response.
Class C
127
Nerve-locating anaesthesia
needle
A sterile, electrically-insulated needle
intended to be used with a syringe
and pulse generator to function as: 1)
an electrode during nerve/nerve
plexus location; and 2) as a conduit
for administration of a local
anaesthetic during peripheral nerve-
blocking.
Class C
128
Nerve-locating system
(Intraoperative nerve
monitor)
A multicomponent assembly of
electrically-powered devices intended
to locate a nerve by applying an
electrical stimulus with a probe and
observing muscle responses. It does
not display electromyography (EMG)
readings. It is used during nerve
function assessment and/or
intraoperatively to locate nerves to
reduce accidental injury.
Class B/C
129 Nerve-locating system probe, reusable/single use A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. This is a reusable device intended to be sterilized prior to use. Class C 130 Neural-tissue balloon catheter It is intended for the compression or dilation of neural tissue under direct endoscopic or fluoroscopic vision typically for the treatment of trigeminal neuralgia.
eural-tissue balloon
catheter
It is intended for the compression or
dilation of neural tissue under direct
endoscopic or fluoroscopic vision
typically for the treatment of trigeminal
neuralgia. It may be supplied with a
stylet.
Class D
131
Neurological endoscope
A neurological endoscope is an
instrument with a light source intended
for the visual examination and
treatment of the brain (e.g., ventricles,
hydrocephalus) and/or spine and
contents.
Class C
132
Neurological stereotactic
surgery system
An assembly of devices intended for
precisely positioning probes, other
instruments, or implantable devices
during neurosurgery. The system may
include computerized functions to
store diagnostic images used for
image-guided surgery. Intended to
store diagnostic images used for
image-guided neurosurgery.
Class C
133
Neuromuscular motion
disorder ambulatory
recorder/analyser
An assembly of devices intended for
24-hour recording of body movements
of a patient affected by a
neuromuscular kinetic disorder (e.g.,
Parkinson’s disease) for analysis.
Class B
134
Neuromuscular
rehabilitation software
A software program intended to be
used by a patient whose
neuromuscular abilities have been
impaired by a disease/condition (e.g.,
Parkinson’s, stroke, traumatic brain
injury) to help train and regain
neuromuscular control (e.g., balance,
strength, speech) through guided
activities (e.g., visuomotor stimulating
onscreen patterns, tailored exercise
regimes, interactive games).
train and regain neuromuscular control (e.g., balance, strength, speech) through guided activities (e.g., visuomotor stimulating onscreen patterns, tailored exercise regimes, interactive games). It is intended to be used on a non-medical computerized device (e.g., tablet, smartphone) for use in the home; it is not intended to interface with external biomechanical function analysis equipment. Class B
135 Neuromuscular transmission electrical skin sensor Intended to detect electrical neuromuscular transmission (NMT) signals, for assessing the degree of neuromuscular block in a patient. Class C 136 Neuromuscular transmission electrode A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. This is a single-use device. Class B 137 Neuromuscular transmission electrode/sensor lead An insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (NMT) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation to determine the level of neuromuscular block and the localization of a nerve in an area of the body.
y and a patient
monitoring system module, intended
for the monitoring of patient relaxation
to determine the level of
neuromuscular block and the
localization of a nerve in an area of
the body.
Class B
138
Neuromuscular
transmission lead set,
reusable
A device(s) intended exclusively to
conduct electrical neuromuscular
transmission (NMT) signals to/from an
array of neuromuscular electrodes
attached to the surface of the skin of
the hand and forearm, or the foot. The
patient-contact electrodes are not
included.
Class B
139
Neuromuscular
transmission motion sensor
Intended to be placed on the thumb
and index finger of a patient to detect
movements and convert them into
electrical neuromuscular transmission
(NMT) signals during nerve
stimulation.
Class B
140
Neuromuscular
transmission regional
anaesthesia block adaptor
A device intended to conduct electrical
signals between an integrated
electrode connection clip and an
injection needle on a patient’s body,
via a neuromuscular transmission
(NMT) sensor cable, and
subsequently to a patient monitoring
module for the localization of a nerve
in an area of the body for the
administration of regional
anaesthesia.
Class B
ransmission
(NMT) sensor cable, and
subsequently to a patient monitoring
module for the localization of a nerve
in an area of the body for the
administration of regional
anaesthesia.
Class B
141
Neurophysiologic
monitoring system
It is intended to monitor and provide
electrical stimuli to spinal nerves or
other neural pathways (may include
the brain) during intraoperative
surgery or intensive care, typically to
reduce the incidence of accidental
injury during instrumented spine
surgery, or to diagnose acute
dysfunction in corticospinal conduction
(e.g., due to traction, shearing,
laceration, compression, or vascular
insufficiency). It typically displays
electroencephalogram (EEG),
electromyogram (EMG), and/or
evoked responses.
Class C
142
Neuropsychiatric
interpretive
electroencephalograph
assessment aid
The neuropsychiatric interpretive
electroencephalograph assessment
aid is a prescription device that uses a
patient's electroencephalograph
(EEG) to provide an interpretation of
the patient's neuropsychiatric
condition. The neuropsychiatric
interpretive EEG assessment aid is
used only as an assessment aid for a
medical condition for which there
exists other valid methods of
diagnosis.
Class C
143
Neurosurgical bone flap
elevator
A hand-held, manually-operated
surgical instrument intended to be
used to pry up, lift, and position a
bone flap in a neurosurgical procedure
upon the skull.
3
Neurosurgical bone flap
elevator
A hand-held, manually-operated
surgical instrument intended to be
used to pry up, lift, and position a
bone flap in a neurosurgical procedure
upon the skull.
Class B
144
Neurosurgical curette,
single-use
A hand-held manual surgical
instrument intended to be used to
scrape and debride tissue from a bone
surface (e.g., cancellous vertebral
bone of the spine) or a cavity wall
during a neurosurgical procedure.It is
typically used during percutaneous
kyphoplasty to treat vertebral
compression fractures (VCFs), or
during craniotomy or brain
microsurgery.
Class B
145
Neurosurgical head holder
(skull clamp)
A neurosurgical head holder (skull
clamp) is a device used to clamp the
patient's skull to hold head and neck
in a particular position during surgical
procedures.
Class B
146
Neurosurgical micro
targeting drive
A calibrated guide mechanism used
by a surgeon to manually operate a Z-
axis positioner which allows extremely
accurate placement of a single or
multiple microelectrodes, stimulation
electrodes, probes, instruments, or
implantable devices, along a chosen
track during neurosurgery on the
brain. It is intended to be used with a
neurosurgical stereotactic system.
Class B
147
Neurosurgical microscope
Designed to magnify minute structures
within the neurological fields for
surgery, typically the brain or spine or
surroundings in the performance of
neurological surgical procedures
which require high magnification by
transmitted light.
in the neurological fields for
surgery, typically the brain or spine or
surroundings in the performance of
neurological surgical procedures
which require high magnification by
transmitted light.
Class B
148
Neurosurgical probe
A hand-held manual surgical
instrument designed for
exploring/dissecting intracranial
structures during a surgical procedure.
Class B
149
Neurosurgical procedure
kit, non-medicated,
reusable
A collection of various manual
neurosurgical instruments, dressings
and the necessary materials used to
perform a neurosurgical procedure. It
does not contain pharmaceuticals.
Class B
150
Neurosurgical procedure
kit, non-medicated, single-
use
A collection of various sterile, manual
neurosurgical instruments, dressings
and the necessary materials used to
perform a neurosurgical procedure. It
does not contain pharmaceuticals.
Class B
151
Neurosurgical retraction
cannula
A single-lumen surgical device
designed to be used with an obturator
to atraumatically displace brain
tissues without tissue penetration to
create a surgical access corridor to a
specific lesion/abnormality within the
brain. It may include depth markings.
This is a single-use device.
Class C
152
cannula manipulation tool
A hand-held, manual surgical device
intended to be used to manipulate the
position of a neurosurgical retraction
cannula during brain surgery. It is
intended to attach to the cannula. It is
not intended to manipulate tissues
directly.
nded to be used to manipulate the
position of a neurosurgical retraction
cannula during brain surgery. It is
intended to attach to the cannula. It is
not intended to manipulate tissues
directly.
Class B
153
cannula stabilization tool
A hand-held, manual surgical device
intended to be used to stabilize the
position of a neurosurgical retraction
cannula during brain surgery. It is
typically clamped to a retraction
assembly. This is a single-use device.
Class B
154
obturator
A hand-held manual surgical
instrument intended to fill the lumen of
a neurosurgical retraction cannula (not
included) to facilitate atraumatic
displacement of brain tissues and
insertion of the retraction cannula
during brain surgery.
Class C
155
obturator mounting rod
(Navigation stylet)
A hand-held surgical device intended
to be connected to a neurosurgical
retraction obturator during brain
surgery to allow mounting of devices
(e.g., navigational devices) to the
obturator/cannula assembly during
introduction into brain tissues. It is not
intended to manipulate tissues
directly.
Class C
156
obturator/probe adaptor
A manual device intended to connect
a neurosurgical retraction obturator to
a probe (e.g.,
stereotactic/electromagnetic surgery
system probe), typically of
incompatible sizes. The obturator and
probe are not included.
to connect
a neurosurgical retraction obturator to
a probe (e.g.,
stereotactic/electromagnetic surgery
system probe), typically of
incompatible sizes. The obturator and
probe are not included.
Class A
157
system, brain
A frame-like assembly of surgical
instruments/devices intended to be
used to create a self-locking, self-
retaining mechanism dedicated to the
temporary parting of brain tissue
during neurosurgery. This may be a
reusable device.
Class B
158
system, spinal
A frame-like assembly of surgical
instruments/devices intended to be
used to create a self-locking, self-
retaining mechanism dedicated to the
temporary parting of dorsal tissue to
enable access for spinal surgery. This
may be a reusable device.
Class B
159
Neurosurgical rongeur
A hand-held manual surgical
instrument designed with a
cutting/biting action used for the
removal of bone, e.g., pieces of the
skull, during a neurosurgical
intervention.
Class B
160
Neurosurgical scissors
A hand-held manual surgical
instrument designed to cut tissue
(e.g., dura mater, neural soft-tissue)
during neurosurgery.
Class B
161
Neurosurgical sponge
A sterile absorbent material intended
to be used on the brain to remove
blood and other fluids during an
operation. This is a single-use device.
Class C
ry.
Class B
161
Neurosurgical sponge
A sterile absorbent material intended
to be used on the brain to remove
blood and other fluids during an
operation. This is a single-use device.
Class C
162
Neurosurgical ultrasound
navigation system
Intended for intraoperative imaging of
the brain for precise navigation during
brain surgery (e.g., resection of
malignant brain tumours, treatment of
vascular malformations).
Class B
163
Neurosurgical ultrasound
navigation system optical
tracking unit
A component of a neurosurgical
ultrasound (US) navigation system
used to track the position of all the
localizers/spatial markers during
intraoperative imaging and to supply
the US system with valid positional
data.
Class B
164
Neurosurgical ventricular
access
guide/Neurosurgical
catheter guide
A device intended to guide a catheter
into the brain. It can be used to place
ventricular catheters or other
catheters.
Class D
165
Neurovascular
embolization coil
A non-bioabsorbable, implantable
device intended to induce a
neurovascular thrombosis to treat an
intracranial aneurysm and/or
neurovascular arteriovenous
malformation (AVM); it may also be
intended to treat non-neurovascular
malformations. Disposable devices
associated with implantation (e.g.,
delivery wire, catheter) may be
included.
Class D
166
Neurovascular
embolization plug
A non-bioabsorbable material (e.g.,
gel, liquid) intended to be implanted in
a neurovascular blood vessel, to
obstruct blood flow to treat a brain
arteriovenous malformation (bAVM).
ization plug A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation. Class D 167 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system A non-electroencephalogram (non- EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure. Class C
168 Non-implantable intracerebral cannula, reusable/single use A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. Class D 169 Nonpowered neurosurgical instrument A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue.
neurosurgical
instrument
A nonpowered neurosurgical
instrument is a hand instrument or an
accessory to a hand instrument used
during neurosurgical procedures to
cut, hold, or manipulate tissue. It
includes specialized chisels,
osteotomes, curettes, dissectors,
elevators, forceps, gouges, hooks,
surgical knives, rasps, scissors,
separators, spatulas, spoons, blades,
blade holders, blade breakers, probes,
etc.
Class B
170
Olfactometry system
Intended to determine the response of
humans to odours delivered through
the nose, including irritants.
Class C
171
Opioid withdrawal/irritable
bowel symptom-relief
periauricular nerve
percutaneous electrical
stimulator
A body-worn, electronic device
intended to provide percutaneous
electrical nerve field stimulation
(PENFS) applied close to
cranial/peripheral nerves around the
external ear to achieve remote
symptom relief mediated by central
nervous system (CNS) pathways and
structures [e.g., amygdala, spinal cord
neurons]. It may be used for opioid
withdrawal symptoms (e.g., bone/joint
aches, tremor, anxiety), or irritable
bowel syndrome [IBS]-associated
functional abdominal pain (FAP).
Class C
172
Patient monitoring system
module, nerve location
Intended to be plugged into a parent
patient monitoring device (not
included) for the localization of a
nerve in an area of the body. It is
intended to be used during the
administration of relaxants and local
anaesthesia.
a parent
patient monitoring device (not
included) for the localization of a
nerve in an area of the body. It is
intended to be used during the
administration of relaxants and local
anaesthesia.
Class C
173
Peripheral nerve
implantable analgesic
system and its components
The implantable system is intended to
deliver episodic electrical stimulation
to the epidural space in/near a
peripheral nerve (e.g., in a limb) for
the relief/treatment of acute and/or
chronic intractable pain [e.g., chronic
low back pain (CLBP)]. It may have an
external control unit.
Class C
174 Peritoneal/atrial cerebrospinal fluid catheter A flexible tube intended to be implanted as the distal component of a ventriculo-peritoneal/atrial shunt, to channel cerebrospinal fluid (CSF) to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. Class D 175 Photodiode subretinal prosthesis system Intended to provide visual function to a patient with vision loss due to retinal degeneration by detecting light, converting it into electrical signals, and relaying them to the retina for neural stimulation. Class C 176 Physical therapy ultrasound/neuro muscular stimulation system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and/or to help reduce muscle spasms and pain.
simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and/or to help reduce muscle spasms and pain. It may also be used to promote the removal of metabolic by-products from injured muscles while applying ultrasound treatments. Class C 177 Polysomnography analyser A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro- oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). Class B 178 Rheoencephalograph It is intended to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area. Class D 179 Scalp clip It is intended to stop bleeding during surgery on the scalp Class C 180 Scoliosis- treatment system Intended to apply electrical stimuli to the spinal musculature to produce a force that stabilizes or limits the progression of the spinal lateral curvature (i.e., scoliosis). Class D 181 Skull plate anvil It is intended to be used to form alterable skull plates in the proper Class A
izes or limits the progression of the spinal lateral curvature (i.e., scoliosis). Class D 181 Skull plate anvil It is intended to be used to form alterable skull plates in the proper Class A
shape to fit the curvature of a patient's skull. 182 Skull punch It is intended to be used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means Class B 183 Skullplate screwdriver, reusable It is intended to be used to fasten cranioplasty plates or skullplates to a patient's skull by screws. Class A 184 Spinal cord nerve implantable analgesic system and its components The implantable system is intended to deliver episodic electrical stimulation to the epidural space of the spinal cord (e.g., lumbar, truncal) for the relief/treatment of acute and/or chronic intractable pain [e.g., chronic low back pain (CLBP)]. It may have an external control unit. Class D 185 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system control unit A portable, external, electrically- powered component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to be used by a patient to telemetrically control its function (on/off) for delivery of treatment cycles.
inal
cord/peripheral nerve implantable
analgesic electrical stimulation system
intended to be used by a patient to
telemetrically control its function
(on/off) for delivery of treatment
cycles.
Class C
186
Spinal needle
It is intended to withdraw a sample of
cerebrospinal fluid (CSF), assist
introduction of a spinal guidewire or
catheter (e.g., lumboperitoneal shunt,
intrathecal catheter), and/or deliver
contrast media and/or anaesthetic or
analgesic agents intrathecally
(subarachnoid) or into a vertebral disc,
either directly or using the needle-
through-needle technique.
Class C
187
Spinal port/catheter
An implantable device intended to
provide access to the subarachnoid
(intrathecal) space of the spinal
column for infusion (e.g.,
chemotherapeutic agents, pain
relieving drugs) and/or drainage [e.g.,
cerebrospinal fluid (CSF)].
Class D
188
Spinal shaver system
A hand-held powered surgical
instrument intended for bone and soft
tissue resection during spinal surgery.
Class B
189
Spinal shaver system
blade
A cutting device designed for use in a
powered spinal decompression shaver
system handpiece (not included) for
bone and soft-tissue resection during
spinal surgery.
Class B
190
Spinal shaver system
handpiece
A power-driven hand-held device used
as a component of a shaver system
which is used for the removal of
Class B
e resection during spinal surgery. Class B 190 Spinal shaver system handpiece A power-driven hand-held device used as a component of a shaver system which is used for the removal of Class B
bone/brawn/cartilage during spinal surgery. 191 Stereotactic neuronavigation/planning system Intended to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. Class B 192 Stereotactic radiosurgical system Intended to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array; typically used to treat brain, neck, breast and spinal tumours. Class D 193 Subdermal needle electrode A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation.
rical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. Class C 194 Surgical optical-tracking spatial marker cranial anchor (Cranial localizer holder for surgical navigation tracking system) An invasive component of a surgical navigation and/or device tracking system (e.g., optical/electromagnetic device tracking system, computer- assisted neurosurgical ultrasound navigation system, surgical microscope equipped with a tracking camera) intended for intraoperative fixation to a patient’s skull to securely receive optical spatial markers/holders. Class B 195 Tibial nerve percutaneous incontinence-control system Intended to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). Class C
196 Transcranial magnetic stimulation system An assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves.
neurological,
psychiatric and/or cognitive conditions
(e.g., Alzheimer's disease, major
depressive disorder, pain) through
noninvasive magnetic stimulation of
the brain and/or peripheral nerves.
Class C
197
Transcranial
system, continuous-
current and pulsed-current
Intended for one or more
psychiatric\neurological therapy
types [e.g., transcranial direct current
stimulation (tDCS), transcranial
alternating current stimulation (tACS)]
and to induce a state resembling that
of chemically-induced anaesthesia for
treating one or more psychiatric
disorders which may include anxiety,
depression, insomnia, and/or
addiction.
Class C
198
Transvenous phrenic nerve
control unit
Intended to configure/deliver
stimulation of the phrenic nerve, via a
transvenous electrode, to cause
contraction of the diaphragm in
conjunction with mechanical
ventilation to assist earlier ventilation
weaning.
Class D
199
Vagus nerve electrical
stimulation system
programmer
It is intended to program the strength
and duration of the electrical impulses
for a vagus nerve electrical stimulation
system.
Class C
200
Ventricular cerebrospinal
fluid drainage
catheterization kit
A collection of sterile devices intended
for short-term access to the brain
ventricles to drain cerebrospinal fluid
(CSF) as a means of reducing CSF
volume and intracranial pressure
(ICP). It includes an intracerebral
infusion/drainage catheter and
devices intended for catheter insertion
(e.g. stylet) and CSF collection (e.g.,
drip chamber, drainage bag, tubing
set).
ssure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). Class D 201 Ventriculoperitoneal shunt An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). Disposable devices associated with implantation may be included. Class D
202 Ventriculo-peritoneal/atrial shunt An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). Disposable devices associated with implantation may be included. Class D
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