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(b) Classification. Class II. (51 FR 40389, Nov. 6, 1986)

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

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$868.5790 Tracheal tube stylet.

(a) Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996]

$ 868.5810 Airway connector.

(a) Identification. An airway nector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

$868.5820 Dental protector.

(a) Identification. A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

8 868.5795 Tracheal tube cleaning

brush. (a) Identification. A tracheal tube cleaning brush is a device consisting of a brush with plastic bristles intended to clean tracheal cannula devices after their removal from patients.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. (51 FR 40388, Nov. 6, 1986)

8 868.5830 Autotransfusion apparatus.

(a) Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

(b) Classification. Class II (performance standards).

8868.5860 Pressure tubing and acces

sories. (a) Identification. Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996)

$868.5800 Tracheostomy tube and tube

cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

$ 868.5870 Nonrebreathing valve.

(a) Identification. Anonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

(b) Classification. Class II (performance standards).

tion by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

(b) Classification. Class II (performance standards).

8868.5880 Anesthetic vaporizer.

(a) Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.

(b) Classification. Class II (performance standards). $ 868.5895 Continuous ventilator.

(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

(b) Classification. Class II (performance standards).

$868.5955 Intermittent mandatory

ventilation attachment. (a) Identification. An intermittent mandatory ventilation (IMV) attachment is a device attached to a mechanical ventilator that allows spontaneous breathing by a patient while providing mechanical ventilation at a preset rate.

(b) Classification. Class II (performance standards).

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Subpart G-Miscellaneous $868.6100 Anesthetic cabinet, table, or

tray. (a) Identification. An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989)

$868.6250 Portable air compressor.

(a) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

(b) Classification. Class II (performance standards).

$ 868.6400 Calibration gas.

(a) Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996]

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$868.6175 Cardiopulmonary

gency cart. (a) Identification. A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989)

$868.6700 Anesthesia stool.

(a) Identification. An anesthesia stool is a device intended for use as a stool for the anesthesiologist in the operating room.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 31142, July 16, 1982, as amended at 54 FR 25049, June 12, 1989)

$868.6225 Nose clip.

(a) Identification. A nose clip is a device intended to close a patient's external nares (nostrils) during diagnostic or therapeutic procedures.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989)

8868.6810 Tracheobronchial suction

catheter. (a) Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

(b) Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $868.9. (47 FR 31142, July 16, 1982, as amended at 65 FR 2314, Jan. 14, 2000)

$868.6820 Patient position support.

(a) Identification. A patient position support is a device intended to maintain the position of an anesthetized patient during surgery.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996)

8868.6885 Medical gas yoke assembly.

(a) Identification. A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan, 16, 1996)

870.1370 Catheter tip occluder. 870.1380 Catheter stylet. 870.1390 Trocar. 870.1425 Programmable diagnostic com

puter. 870.1435 Single-function, preprogrammed di

agnostic computer. 870.1450 Densitometer. 870.1650 Angiographic injector and syringe. 870.1660 Indicator injector. 870.1670 Syringe actuator for an injector. 870.1750 External programmable pacemaker

pulse generator. 870.1800 Withdrawal-infusion pump. 870.1875 Stethoscope. 870.1915 Thermodilution probe.

Subpart C-Cardiovascular Monitoring

Devices

PART 870—CARDIOVASCULAR

DEVICES

Subpart A-General Provisions

Sec. 870.1 Scope. 870.3 Effective dates of requirement for pre

market approval. 870.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B-Cardiovascular Diagnostic

Devices

870.2050 Biopotential amplifier and signal

conditioner. 870.2060 Transducer signal amplifier and sig.

nal conditioner. 870.2100 Cardiovascular blood flowmeter. 870.2120 Extravascular blood flow probe. 870.2300 Cardiac monitor (including

cardiotachometer and rate alarm). 870.2310 Apex

cardiograph (vibrocardiograph). 870.2320 Ballistocardiograph. 870.2330 Echocardiograph. 870.2340 Electrocardiograph. 870.2350 Electrocardiograph lead switching

adaptor. 870.2360 Electrocardiograph electrode. 870.2370 Electrocardiograph surface elec

trode tester. 870.2390 Phonocardiograph. 870.2400 Vectorcardiograph. 870.2450 Medical cathode-ray tube display. 870.2600 Signal isolation system. 870.2620 Line isolation monitor. 870.2640 Portable leakage current alarm. 870.2675 Oscillometer. 870.2700 Oximeter. 870.2710 Ear oximeter. 870.2750 Impedance phlebograph. 870.2770 Impedance plethysmograph. 870.2780 Hydraulic, pneumatic, or photo

electric plethysmographs. 870.2800 Medical magnetic tape recorder. 870.2810 Paper chart recorder. 870.2840 Apex cardiographic transducer. 870.2850 Extravascular blood pressure trans

ducer. 870.2860 Heart sound transducer. 870.2870 Catheter tip pressure transducer. 870.2880 Ultrasonic transducer. 870.2890 Vessel occlusion transducer. 870.2900 Patient transducer and electrode

cable (including connector). 870.2910 Radiofrequency physiological sigSubpart D-Cardiovascular Prosthetic

870.1025 Arrhythmia detector and alarm.
870.1100 Blood pressure alarm.
870.1110 Blood pressure computer.
870.1120 Blood pressure cuff.
870.1130 Noninvasive blood pressure meas-

urement system.
870.1140 Venous blood pressure manometer.
870.1200 Diagnostic intravascular catheter.
870.1210 Continuous flush catheter.
870.1220 Electrode recording catheter or

electrode recording probe. 870.1230 Fiberoptic oximeter catheter. 870.1240 Flow-directed catheter. 870.1250 Percutaneous catheter. 870.1270 Intracavitary phonocatheter sys

tem. 870.1280 Steerable catheter. 870.1290 Steerable catheter control system. 870.1300 Catheter cannula. 870.1310 Vessel dilator for percutaneous

catheterization. 870.1330 Catheter guide wire. 870.1340 Catheter introducer. 870.1350 Catheter balloon repair kit. 870.1360 Trace microsphere.

nal transmitter and receiver. 870.2920 Telephone electrocardiograph

transmitter and receiver.

Devices

of

870.3250 Vascular clip. 870.3260 Vena cava clip. 870.3300 Arterial embolization device. 870.3375 Cardiovascular intravascular filter. 870.3450 Vascular graft prosthesis of less

than 6 millimeters diameter. 870.3460 Vascular graft prosthesis of 6 milli

meters and greater diameter. 870.3470 Intracardiac patch or pledget made

polypropylene, polyethylene terephthalate, or polytetrafluoro

ethylene. 870.3535 Intra-aortic balloon and control

system. 870.3545 Ventricular bypass (assist) device. 870.3600 External pacemaker pulse gener

ator. 870.3610 Implantable pacemaker pulse gen

erator. 870.3620 Pacemaker lead adaptor. 870.3630 Pacemaker generator function ana

lyzer. 870.3640 Indirect pacemaker generator func

tion analyzer. 870.3650 Pacemaker polymeric mesh bag. 870.3670 Pacemaker charger. 870.3680 Cardiovascular permanent or tem

porary pacemaker electrode. 870.3690 Pacemaker test magnet. 870.3700 Pacemaker programmers. 870.3710 Pacemaker repair or replacement

material. 870.3720 Pacemaker electrode function test

er. 870.3730 Pacemaker service tools. 870.3800 Annuloplasty ring. 870.3850 Carotid sinus nerve stimulator. 870.3925 Replacement heart valve. 870.3935 Prosthetic heart valve holder. 870.3945 Prosthetic heart valve sizer.

870.4290 Cardiopulmonary bypass adaptor,

stopcock, manifold, or fitting. 870.4300 Cardiopulmonary bypass gas con

trol unit. 870.4310 Cardiopulmonary bypass coronary

pressure gauge. 870.4320 Cardiopulmonary bypass pulsatile

flow generator. 870.4330 Cardiopulmonary bypass on-line

blood gas monitor. 870.4340 Cardiopulmonary by pass level sens

ing monitor and/or control. 870.4350 Cardiopulmonary

bypass oxygenator. 870.4360 Nonroller-type cardiopulmonary

bypass blood pump. 870.4370 Roller-type cardiopulmonary by

pass blood pump. 870.4380 Cardiopulmonary bypass pump

speed control. 870.4390 Cardiopulmonary bypass pump tub

ing. 870.4400 Cardiopulmonary bypass blood res

ervoir. 870.4410 Cardiopulmonary bypass in-line

blood gas sensor. 870.4420 Cardiopulmonary bypass cardi

otomy return sucker. 870.4430 Cardiopulmonary

bypass intracardiac suction control. 870.4450 Vascular clamp. 870.4475 Surgical vessel dilator. 870.4500 Cardiovascular surgical instru

ments. 870.4875 Intraluminal artery stripper. 870.4885 External vein stripper.

Subpart F-Cardiovascular Therapeutic

Devices

Subpart E-Cardiovascular Surgical

Devices

870.4075 Endomyocardial biopsy device. 870.4200 Cardiopulmonary bypass accessory

equipment. 870.4205 Cardiopulmonary bypass bubble de

tector. 870.4210 Cardiopulmonary bypass vascular

catheter, cannula, or tubing. 870.4220 Cardiopulmonary bypass heart-lung

machine console. 870.4230 Cardiopulmonary bypass defoamer. 870.4240 Cardiopulmonary bypass heat ex

changer. 870.4250 Cardiopulmonary bypass tempera

ture controller. 870.4260 Cardiopulmonary bypass arterial

line blood filter. 870.4270 Cardiopulmonary bypass cardi

otomy suction line blood filter. 870.4280 Cardiopulmonary prebypass filter.

870.5050 Patient care suction apparatus. 870.5150 Embolectomy catheter. 870.5175 Septostomy catheter. 870.5200 External cardiac compressor. 870.5225 External counter-pulsating device. 870.5300 DC-defibrillator (including paddles). 870.5325 Defibrillator tester. 870.5550 External transcutaneous cardiac

pacemaker (noninvasive). 870.5800 Compressible limb sleeve. 870.5900 Thermal regulating system. 870.5925 Automatic rotating tourniquet.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

SOURCE: 45 FR 7907-7971, Feb. 5, 1980, unless otherwise noted.

Subpart A-General Provisions

8870.1 Scope.

(a) This part sets forth the classification of cardiovascular devices intended for human use that are in commercial distribution.

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