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Electronic Code of Federal Regulations

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e-CFR Data is current as of October 21, 2014

Title 21Chapter ISubchapter HPart 870


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 870—CARDIOVASCULAR DEVICES

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Subpart A—GENERAL PROVISIONS

§870.1
Scope.
§870.3
Effective dates of requirement for premarket approval.
§870.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B—CARDIOVASCULAR DIAGNOSTIC DEVICES

§870.1025
Arrhythmia detector and alarm (including ST-segment measurement and alarm).
§870.1100
Blood pressure alarm.
§870.1110
Blood pressure computer.
§870.1120
Blood pressure cuff.
§870.1130
Noninvasive blood pressure measurement 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 system.
§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.
§870.1370
Catheter tip occluder.
§870.1380
Catheter stylet.
§870.1390
Trocar.
§870.1425
Programmable diagnostic computer.
§870.1435
Single-function, preprogrammed diagnostic 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.
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Subpart C—CARDIOVASCULAR MONITORING DEVICES

§870.2050
Biopotential amplifier and signal conditioner.
§870.2060
Transducer signal amplifier and 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 electrode 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 photoelectric plethysmographs.
§870.2800
Medical magnetic tape recorder.
§870.2810
Paper chart recorder.
§870.2840
Apex cardiographic transducer.
§870.2850
Extravascular blood pressure transducer.
§870.2855
Implantable Intra-aneurysm Pressure Measurement System.
§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 signal transmitter and receiver.
§870.2920
Telephone electrocardiograph transmitter and receiver.
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Subpart D—CARDIOVASCULAR PROSTHETIC DEVICES

§870.3250
Vascular clip.
§870.3260
Vena cava clip.
§870.3300
Vascular embolization device.
§870.3375
Cardiovascular intravascular filter.
§870.3450
Vascular graft prosthesis.
§870.3460
Endovascular Suturing System.
§870.3470
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
§870.3535
Intra-aortic balloon and control system.
§870.3545
Ventricular bypass (assist) device.
§870.3600
External pacemaker pulse generator.
§870.3610
Implantable pacemaker pulse generator.
§870.3620
Pacemaker lead adaptor.
§870.3630
Pacemaker generator function analyzer.
§870.3640
Indirect pacemaker generator function analyzer.
§870.3650
Pacemaker polymeric mesh bag.
§870.3670
Pacemaker charger.
§870.3680
Cardiovascular permanent or temporary pacemaker electrode.
§870.3690
Pacemaker test magnet.
§870.3700
Pacemaker programmers.
§870.3710
Pacemaker repair or replacement material.
§870.3720
Pacemaker electrode function tester.
§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.
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Subpart E—CARDIOVASCULAR SURGICAL DEVICES

§870.4075
Endomyocardial biopsy device.
§870.4200
Cardiopulmonary bypass accessory equipment.
§870.4205
Cardiopulmonary bypass bubble detector.
§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 exchanger.
§870.4250
Cardiopulmonary bypass temperature controller.
§870.4260
Cardiopulmonary bypass arterial line blood filter.
§870.4270
Cardiopulmonary bypass cardiotomy suction line blood filter.
§870.4280
Cardiopulmonary prebypass filter.
§870.4290
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
§870.4300
Cardiopulmonary bypass gas control 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 bypass level sensing monitor and/or control.
§870.4350
Cardiopulmonary bypass oxygenator.
§870.4360
Nonroller-type cardiopulmonary bypass blood pump.
§870.4370
Roller-type cardiopulmonary bypass blood pump.
§870.4380
Cardiopulmonary bypass pump speed control.
§870.4390
Cardiopulmonary bypass pump tubing.
§870.4400
Cardiopulmonary bypass blood reservoir.
§870.4410
Cardiopulmonary bypass in-line blood gas sensor.
§870.4420
Cardiopulmonary bypass cardiotomy return sucker.
§870.4430
Cardiopulmonary bypass intracardiac suction control.
§870.4450
Vascular clamp.
§870.4475
Surgical vessel dilator.
§870.4500
Cardiovascular surgical instruments.
§870.4875
Intraluminal artery stripper.
§870.4885
External vein stripper.
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Subpart F—CARDIOVASCULAR THERAPEUTIC DEVICES

§870.5050
Patient care suction apparatus.
§870.5100
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
§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).
§870.5310
Automated external defibrillator.
§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.


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