Title 21

PART 870

Part 870 - Cardiovascular Devices

PART 870 - CARDIOVASCULAR DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:45 FR 7907, Feb. 5, 1980, unless otherwise noted. Editorial Note:Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.22.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.22.1.1.1SECTION 870.1
   870.1 Scope.
21:8.0.1.1.22.1.1.2SECTION 870.3
   870.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.22.1.1.3SECTION 870.9
   870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.22.2SUBPART B
Subpart B - Cardiovascular Diagnostic Devices
21:8.0.1.1.22.2.1.1SECTION 870.1025
   870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
21:8.0.1.1.22.2.1.2SECTION 870.1100
   870.1100 Blood pressure alarm.
21:8.0.1.1.22.2.1.3SECTION 870.1110
   870.1110 Blood pressure computer.
21:8.0.1.1.22.2.1.4SECTION 870.1120
   870.1120 Blood pressure cuff.
21:8.0.1.1.22.2.1.5SECTION 870.1130
   870.1130 Noninvasive blood pressure measurement system.
21:8.0.1.1.22.2.1.6SECTION 870.1140
   870.1140 Venous blood pressure manometer.
21:8.0.1.1.22.2.1.7SECTION 870.1200
   870.1200 Diagnostic intravascular catheter.
21:8.0.1.1.22.2.1.8SECTION 870.1210
   870.1210 Continuous flush catheter.
21:8.0.1.1.22.2.1.9SECTION 870.1220
   870.1220 Electrode recording catheter or electrode recording probe.
21:8.0.1.1.22.2.1.10SECTION 870.1230
   870.1230 Fiberoptic oximeter catheter.
21:8.0.1.1.22.2.1.11SECTION 870.1240
   870.1240 Flow-directed catheter.
21:8.0.1.1.22.2.1.12SECTION 870.1250
   870.1250 Percutaneous catheter.
21:8.0.1.1.22.2.1.13SECTION 870.1251
   870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
21:8.0.1.1.22.2.1.14SECTION 870.1255
   870.1255 Balloon aortic valvuloplasty catheter.
21:8.0.1.1.22.2.1.15SECTION 870.1270
   870.1270 Intracavitary phonocatheter system.
21:8.0.1.1.22.2.1.16SECTION 870.1280
   870.1280 Steerable catheter.
21:8.0.1.1.22.2.1.17SECTION 870.1290
   870.1290 Steerable catheter control system.
21:8.0.1.1.22.2.1.18SECTION 870.1300
   870.1300 Catheter cannula.
21:8.0.1.1.22.2.1.19SECTION 870.1310
   870.1310 Vessel dilator for percutaneous catheterization.
21:8.0.1.1.22.2.1.20SECTION 870.1330
   870.1330 Catheter guide wire.
21:8.0.1.1.22.2.1.21SECTION 870.1340
   870.1340 Catheter introducer.
21:8.0.1.1.22.2.1.22SECTION 870.1350
   870.1350 Catheter balloon repair kit.
21:8.0.1.1.22.2.1.23SECTION 870.1360
   870.1360 Trace microsphere.
21:8.0.1.1.22.2.1.24SECTION 870.1370
   870.1370 Catheter tip occluder.
21:8.0.1.1.22.2.1.25SECTION 870.1380
   870.1380 Catheter stylet.
21:8.0.1.1.22.2.1.26SECTION 870.1390
   870.1390 Trocar.
21:8.0.1.1.22.2.1.27SECTION 870.1415
   870.1415 Coronary vascular physiologic simulation software device.
21:8.0.1.1.22.2.1.28SECTION 870.1425
   870.1425 Programmable diagnostic computer.
21:8.0.1.1.22.2.1.29SECTION 870.1435
   870.1435 Single-function, preprogrammed diagnostic computer.
21:8.0.1.1.22.2.1.30SECTION 870.1450
   870.1450 Densitometer.
21:8.0.1.1.22.2.1.31SECTION 870.1650
   870.1650 Angiographic injector and syringe.
21:8.0.1.1.22.2.1.32SECTION 870.1660
   870.1660 Indicator injector.
21:8.0.1.1.22.2.1.33SECTION 870.1670
   870.1670 Syringe actuator for an injector.
21:8.0.1.1.22.2.1.34SECTION 870.1750
   870.1750 External programmable pacemaker pulse generator.
21:8.0.1.1.22.2.1.35SECTION 870.1800
   870.1800 Withdrawal-infusion pump.
21:8.0.1.1.22.2.1.36SECTION 870.1875
   870.1875 Stethoscope.
21:8.0.1.1.22.2.1.37SECTION 870.1915
   870.1915 Thermodilution probe.
21:8.0.1.1.22.3SUBPART C
Subpart C - Cardiovascular Monitoring Devices
21:8.0.1.1.22.3.1.1SECTION 870.2050
   870.2050 Biopotential amplifier and signal conditioner.
21:8.0.1.1.22.3.1.2SECTION 870.2060
   870.2060 Transducer signal amplifier and conditioner.
21:8.0.1.1.22.3.1.3SECTION 870.2100
   870.2100 Cardiovascular blood flowmeter.
21:8.0.1.1.22.3.1.4SECTION 870.2120
   870.2120 Extravascular blood flow probe.
21:8.0.1.1.22.3.1.5SECTION 870.2200
   870.2200 Adjunctive cardiovascular status indicator.
21:8.0.1.1.22.3.1.6SECTION 870.2300
   870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
21:8.0.1.1.22.3.1.7SECTION 870.2310
   870.2310 Apex cardiograph (vibrocardiograph).
21:8.0.1.1.22.3.1.8SECTION 870.2320
   870.2320 Ballistocardiograph.
21:8.0.1.1.22.3.1.9SECTION 870.2330
   870.2330 Echocardiograph.
21:8.0.1.1.22.3.1.10SECTION 870.2340
   870.2340 Electrocardiograph.
21:8.0.1.1.22.3.1.11SECTION 870.2350
   870.2350 Electrocardiograph lead switching adaptor.
21:8.0.1.1.22.3.1.12SECTION 870.2360
   870.2360 Electrocardiograph electrode.
21:8.0.1.1.22.3.1.13SECTION 870.2370
   870.2370 Electrocardiograph surface electrode tester.
21:8.0.1.1.22.3.1.14SECTION 870.2390
   870.2390 Phonocardiograph.
21:8.0.1.1.22.3.1.15SECTION 870.2400
   870.2400 Vectorcardiograph.
21:8.0.1.1.22.3.1.16SECTION 870.2450
   870.2450 Medical cathode-ray tube display.
21:8.0.1.1.22.3.1.17SECTION 870.2600
   870.2600 Signal isolation system.
21:8.0.1.1.22.3.1.18SECTION 870.2620
   870.2620 Line isolation monitor.
21:8.0.1.1.22.3.1.19SECTION 870.2640
   870.2640 Portable leakage current alarm.
21:8.0.1.1.22.3.1.20SECTION 870.2675
   870.2675 Oscillometer.
21:8.0.1.1.22.3.1.21SECTION 870.2700
   870.2700 Oximeter.
21:8.0.1.1.22.3.1.22SECTION 870.2710
   870.2710 Ear oximeter.
21:8.0.1.1.22.3.1.23SECTION 870.2750
   870.2750 Impedance phlebograph.
21:8.0.1.1.22.3.1.24SECTION 870.2770
   870.2770 Impedance plethysmograph.
21:8.0.1.1.22.3.1.25SECTION 870.2780
   870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
21:8.0.1.1.22.3.1.26SECTION 870.2800
   870.2800 Medical magnetic tape recorder.
21:8.0.1.1.22.3.1.27SECTION 870.2810
   870.2810 Paper chart recorder.
21:8.0.1.1.22.3.1.28SECTION 870.2840
   870.2840 Apex cardiographic transducer.
21:8.0.1.1.22.3.1.29SECTION 870.2850
   870.2850 Extravascular blood pressure transducer.
21:8.0.1.1.22.3.1.30SECTION 870.2855
   870.2855 Implantable Intra-aneurysm Pressure Measurement System.
21:8.0.1.1.22.3.1.31SECTION 870.2860
   870.2860 Heart sound transducer.
21:8.0.1.1.22.3.1.32SECTION 870.2870
   870.2870 Catheter tip pressure transducer.
21:8.0.1.1.22.3.1.33SECTION 870.2880
   870.2880 Ultrasonic transducer.
21:8.0.1.1.22.3.1.34SECTION 870.2890
   870.2890 Vessel occlusion transducer.
21:8.0.1.1.22.3.1.35SECTION 870.2900
   870.2900 Patient transducer and electrode cable (including connector).
21:8.0.1.1.22.3.1.36SECTION 870.2910
   870.2910 Radiofrequency physiological signal transmitter and receiver.
21:8.0.1.1.22.3.1.37SECTION 870.2920
   870.2920 Telephone electrocardiograph transmitter and receiver.
21:8.0.1.1.22.4SUBPART D
Subpart D - Cardiovascular Prosthetic Devices
21:8.0.1.1.22.4.1.1SECTION 870.3250
   870.3250 Vascular clip.
21:8.0.1.1.22.4.1.2SECTION 870.3260
   870.3260 Vena cava clip.
21:8.0.1.1.22.4.1.3SECTION 870.3300
   870.3300 Vascular embolization device.
21:8.0.1.1.22.4.1.4SECTION 870.3375
   870.3375 Cardiovascular intravascular filter.
21:8.0.1.1.22.4.1.5SECTION 870.3450
   870.3450 Vascular graft prosthesis.
21:8.0.1.1.22.4.1.6SECTION 870.3460
   870.3460 Endovascular Suturing System.
21:8.0.1.1.22.4.1.7SECTION 870.3470
   870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
21:8.0.1.1.22.4.1.8SECTION 870.3535
   870.3535 Intra-aortic balloon and control system.
21:8.0.1.1.22.4.1.9SECTION 870.3545
   870.3545 Ventricular bypass (assist) device.
21:8.0.1.1.22.4.1.10SECTION 870.3600
   870.3600 External pacemaker pulse generator.
21:8.0.1.1.22.4.1.11SECTION 870.3605
   870.3605 Pacing system analyzer.
21:8.0.1.1.22.4.1.12SECTION 870.3610
   870.3610 Implantable pacemaker pulse generator.
21:8.0.1.1.22.4.1.13SECTION 870.3620
   870.3620 Pacemaker lead adaptor.
21:8.0.1.1.22.4.1.14SECTION 870.3630
   870.3630 Pacemaker generator function analyzer.
21:8.0.1.1.22.4.1.15SECTION 870.3640
   870.3640 Indirect pacemaker generator function analyzer.
21:8.0.1.1.22.4.1.16SECTION 870.3650
   870.3650 Pacemaker polymeric mesh bag.
21:8.0.1.1.22.4.1.17SECTION 870.3670
   870.3670 Pacemaker charger.
21:8.0.1.1.22.4.1.18SECTION 870.3680
   870.3680 Cardiovascular permanent or temporary pacemaker electrode.
21:8.0.1.1.22.4.1.19SECTION 870.3690
   870.3690 Pacemaker test magnet.
21:8.0.1.1.22.4.1.20SECTION 870.3700
   870.3700 Pacemaker programmers.
21:8.0.1.1.22.4.1.21SECTION 870.3710
   870.3710 Pacemaker repair or replacement material.
21:8.0.1.1.22.4.1.22SECTION 870.3720
   870.3720 Pacemaker electrode function tester.
21:8.0.1.1.22.4.1.23SECTION 870.3730
   870.3730 Pacemaker service tools.
21:8.0.1.1.22.4.1.24SECTION 870.3800
   870.3800 Annuloplasty ring.
21:8.0.1.1.22.4.1.25SECTION 870.3850
   870.3850 Carotid sinus nerve stimulator.
21:8.0.1.1.22.4.1.26SECTION 870.3925
   870.3925 Replacement heart valve.
21:8.0.1.1.22.4.1.27SECTION 870.3935
   870.3935 Prosthetic heart valve holder.
21:8.0.1.1.22.4.1.28SECTION 870.3945
   870.3945 Prosthetic heart valve sizer.
21:8.0.1.1.22.5SUBPART E
Subpart E - Cardiovascular Surgical Devices
21:8.0.1.1.22.5.1.1SECTION 870.4075
   870.4075 Endomyocardial biopsy device.
21:8.0.1.1.22.5.1.2SECTION 870.4100
   870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
21:8.0.1.1.22.5.1.3SECTION 870.4200
   870.4200 Cardiopulmonary bypass accessory equipment.
21:8.0.1.1.22.5.1.4SECTION 870.4205
   870.4205 Cardiopulmonary bypass bubble detector.
21:8.0.1.1.22.5.1.5SECTION 870.4210
   870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
21:8.0.1.1.22.5.1.6SECTION 870.4220
   870.4220 Cardiopulmonary bypass heart-lung machine console.
21:8.0.1.1.22.5.1.7SECTION 870.4230
   870.4230 Cardiopulmonary bypass defoamer.
21:8.0.1.1.22.5.1.8SECTION 870.4240
   870.4240 Cardiopulmonary bypass heat exchanger.
21:8.0.1.1.22.5.1.9SECTION 870.4250
   870.4250 Cardiopulmonary bypass temperature controller.
21:8.0.1.1.22.5.1.10SECTION 870.4260
   870.4260 Cardiopulmonary bypass arterial line blood filter.
21:8.0.1.1.22.5.1.11SECTION 870.4270
   870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
21:8.0.1.1.22.5.1.12SECTION 870.4280
   870.4280 Cardiopulmonary prebypass filter.
21:8.0.1.1.22.5.1.13SECTION 870.4290
   870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
21:8.0.1.1.22.5.1.14SECTION 870.4300
   870.4300 Cardiopulmonary bypass gas control unit.
21:8.0.1.1.22.5.1.15SECTION 870.4310
   870.4310 Cardiopulmonary bypass coronary pressure gauge.
21:8.0.1.1.22.5.1.16SECTION 870.4320
   870.4320 Cardiopulmonary bypass pulsatile flow generator.
21:8.0.1.1.22.5.1.17SECTION 870.4330
   870.4330 Cardiopulmonary bypass on-line blood gas monitor.
21:8.0.1.1.22.5.1.18SECTION 870.4340
   870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
21:8.0.1.1.22.5.1.19SECTION 870.4350
   870.4350 Cardiopulmonary bypass oxygenator.
21:8.0.1.1.22.5.1.20SECTION 870.4360
   870.4360 Nonroller-type blood pump.
21:8.0.1.1.22.5.1.21SECTION 870.4370
   870.4370 Roller-type cardiopulmonary bypass blood pump.
21:8.0.1.1.22.5.1.22SECTION 870.4380
   870.4380 Cardiopulmonary bypass pump speed control.
21:8.0.1.1.22.5.1.23SECTION 870.4390
   870.4390 Cardiopulmonary bypass pump tubing.
21:8.0.1.1.22.5.1.24SECTION 870.4400
   870.4400 Cardiopulmonary bypass blood reservoir.
21:8.0.1.1.22.5.1.25SECTION 870.4410
   870.4410 Cardiopulmonary bypass in-line blood gas sensor.
21:8.0.1.1.22.5.1.26SECTION 870.4420
   870.4420 Cardiopulmonary bypass cardiotomy return sucker.
21:8.0.1.1.22.5.1.27SECTION 870.4430
   870.4430 Cardiopulmonary bypass intracardiac suction control.
21:8.0.1.1.22.5.1.28SECTION 870.4450
   870.4450 Vascular clamp.
21:8.0.1.1.22.5.1.29SECTION 870.4475
   870.4475 Surgical vessel dilator.
21:8.0.1.1.22.5.1.30SECTION 870.4500
   870.4500 Cardiovascular surgical instruments.
21:8.0.1.1.22.5.1.31SECTION 870.4510
   870.4510 Apical closure device.
21:8.0.1.1.22.5.1.32SECTION 870.4875
   870.4875 Intraluminal artery stripper.
21:8.0.1.1.22.5.1.33SECTION 870.4885
   870.4885 External vein stripper.
21:8.0.1.1.22.6SUBPART F
Subpart F - Cardiovascular Therapeutic Devices
21:8.0.1.1.22.6.1.1SECTION 870.5050
   870.5050 Patient care suction apparatus.
21:8.0.1.1.22.6.1.2SECTION 870.5100
   870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
21:8.0.1.1.22.6.1.3SECTION 870.5150
   870.5150 Embolectomy catheter.
21:8.0.1.1.22.6.1.4SECTION 870.5175
   870.5175 Septostomy catheter.
21:8.0.1.1.22.6.1.5SECTION 870.5200
   870.5200 External cardiac compressor.
21:8.0.1.1.22.6.1.6SECTION 870.5210
   870.5210 Cardiopulmonary resuscitation (CPR) aid.
21:8.0.1.1.22.6.1.7SECTION 870.5225
   870.5225 External counter-pulsating device.
21:8.0.1.1.22.6.1.8SECTION 870.5300
   870.5300 DC-defibrillator (including paddles).
21:8.0.1.1.22.6.1.9SECTION 870.5310
   870.5310 Automated external defibrillator system.
21:8.0.1.1.22.6.1.10SECTION 870.5325
   870.5325 Defibrillator tester.
21:8.0.1.1.22.6.1.11SECTION 870.5550
   870.5550 External transcutaneous cardiac pacemaker (noninvasive).
21:8.0.1.1.22.6.1.12SECTION 870.5700
   870.5700 Steerable cardiac ablation catheter remote control system.
21:8.0.1.1.22.6.1.13SECTION 870.5800
   870.5800 Compressible limb sleeve.
21:8.0.1.1.22.6.1.14SECTION 870.5900
   870.5900 Thermal regulating system.
21:8.0.1.1.22.6.1.15SECTION 870.5910
   870.5910 Esophageal thermal regulation device.
21:8.0.1.1.22.6.1.16SECTION 870.5925
   870.5925 Automatic rotating tourniquet.