Part 870 — Cardiovascular Devices
Current through Sep 8, 2026
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.
Sections
- § 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).
- § 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.
- § 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
- § 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
- § 870.1255 Balloon aortic valvuloplasty 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.
- § 870.1342 Reverse central venous recanalization system.
- § 870.1345 Intravascular bleed monitor.
- § 870.1350 Catheter balloon repair kit.
- § 870.1360 Trace microsphere.
- § 870.1370 Catheter tip occluder.
- § 870.1380 Catheter stylet.
- § 870.1390 Trocar.
- § 870.1405 Interventional cardiovascular implant simulation software device.
- § 870.1415 Coronary vascular physiologic simulation software device.
- § 870.1420 Coronary artery disease risk indicator using acoustic heart signals.
- § 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.
- § 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.
- § 870.2200 Adjunctive cardiovascular status indicator.
- § 870.2210 Adjunctive predictive cardiovascular indicator.
- § 870.2220 Adjunctive hemodynamic indicator with decision point.
- § 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
- § 870.2310 Apex cardiograph (vibrocardiograph).
- § 870.2320 Ballistocardiograph.
- § 870.2330 Echocardiograph.
- § 870.2340 Electrocardiograph.
- § 870.2345 Electrocardiograph software for over-the-counter use.
- § 870.2350 Electrocardiograph lead switching adaptor.
- § 870.2360 Electrocardiograph electrode.
- § 870.2370 Electrocardiograph surface electrode tester.
- § 870.2380 Cardiovascular machine learning-based notification software.
- § 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.
- § 870.2705 Infant pulse rate and oxygen saturation monitor for over-the-counter use.
- § 870.2710 Ear oximeter.
- § 870.2720 Hyperoxia monitoring device adjunct to pulse oximetry.
- § 870.2750 Impedance phlebograph.
- § 870.2770 Impedance plethysmograph.
- § 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
- § 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
- § 870.2786 Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
- § 870.2790 Photoplethysmograph analysis software for over-the-counter use.
- § 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.
- § 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.
- § 870.3605 Pacing system analyzer.
- § 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.
- § 870.4075 Endomyocardial biopsy device.
- § 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
- § 870.4150 Extracorporeal system for carbon dioxide removal.
- § 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 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.
- § 870.4510 Apical closure device.
- § 870.4600 Extravascular support for an arteriovenous fistula for vascular access.
- § 870.4875 Intraluminal artery stripper.
- § 870.4885 External vein stripper.
- § 870.5050 Patient care suction apparatus.
- § 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
- § 870.5125 Laser-powered inferior vena cava filter retrieval catheter.
- § 870.5150 Embolectomy catheter.
- § 870.5175 Septostomy catheter.
- § 870.5200 External cardiac compressor.
- § 870.5210 Cardiopulmonary resuscitation (CPR) aid.
- § 870.5225 External counter-pulsating device.
- § 870.5300 DC-defibrillator (including paddles).
- § 870.5310 Automated external defibrillator system.
- § 870.5325 Defibrillator tester.
- § 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
- § 870.5600 Adjunctive open loop fluid therapy recommender.
- § 870.5700 Steerable cardiac ablation catheter remote control system.
- § 870.5710 Mechanical deviation device for esophageal protection during cardiac ablation procedures.
- § 870.5720 Temperature regulation device for esophageal protection during cardiac ablation procedures.
- § 870.5800 Compressible limb sleeve.
- § 870.5900 Thermal regulating system.
- § 870.5910 Esophageal thermal regulation device.
- § 870.5925 Automatic rotating tourniquet.