e-CFR data is current as of January 19, 2021
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
Subpart A—GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval. |
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| 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
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| Arrhythmia detector and alarm (including ST-segment measurement and alarm). |
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| Noninvasive blood pressure measurement system. |
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| Venous blood pressure manometer. |
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| Diagnostic intravascular catheter. |
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| Continuous flush catheter. |
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| Electrode recording catheter or electrode recording probe. |
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| Fiberoptic oximeter catheter. |
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| Temporary catheter for embolic protection during transcatheter intracardiac procedures. |
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| Balloon aortic valvuloplasty catheter. |
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| Intracavitary phonocatheter system. |
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| Steerable catheter control system. |
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| Vessel dilator for percutaneous catheterization. |
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| Catheter balloon repair kit. |
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| Coronary vascular physiologic simulation software device. |
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| Programmable diagnostic computer. |
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| Single-function, preprogrammed diagnostic computer. |
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| Angiographic injector and syringe. |
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| Syringe actuator for an injector. |
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| External programmable pacemaker pulse generator. |
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| Withdrawal-infusion pump. |
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Subpart C—CARDIOVASCULAR MONITORING DEVICES
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| Biopotential amplifier and signal conditioner. |
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| Transducer signal amplifier and conditioner. |
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| Cardiovascular blood flowmeter. |
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| Extravascular blood flow probe. |
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| Adjunctive cardiovascular status indicator. |
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| Cardiac monitor (including cardiotachometer and rate alarm). |
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| Apex cardiograph (vibrocardiograph). |
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| Electrocardiograph lead switching adaptor. |
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| Electrocardiograph electrode. |
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| Electrocardiograph surface electrode tester. |
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| Medical cathode-ray tube display. |
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| Portable leakage current alarm. |
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| Impedance plethysmograph. |
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| Hydraulic, pneumatic, or photoelectric plethysmographs. |
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| Medical magnetic tape recorder. |
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| Apex cardiographic transducer. |
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| Extravascular blood pressure transducer. |
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| Implantable Intra-aneurysm Pressure Measurement System. |
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| Catheter tip pressure transducer. |
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| Vessel occlusion transducer. |
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| Patient transducer and electrode cable (including connector). |
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| Radiofrequency physiological signal transmitter and receiver. |
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| Telephone electrocardiograph transmitter and receiver. |
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Subpart D—CARDIOVASCULAR PROSTHETIC DEVICES
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| Vascular embolization device. |
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| Cardiovascular intravascular filter. |
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| Vascular graft prosthesis. |
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| Endovascular Suturing System. |
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| Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
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| Intra-aortic balloon and control system. |
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| Ventricular bypass (assist) device. |
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| External pacemaker pulse generator. |
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| Implantable pacemaker pulse generator. |
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| Pacemaker generator function analyzer. |
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| Indirect pacemaker generator function analyzer. |
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| Pacemaker polymeric mesh bag. |
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| Cardiovascular permanent or temporary pacemaker electrode. |
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| Pacemaker repair or replacement material. |
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| Pacemaker electrode function tester. |
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| Carotid sinus nerve stimulator. |
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| Prosthetic heart valve holder. |
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| Prosthetic heart valve sizer. |
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Subpart E—CARDIOVASCULAR SURGICAL DEVICES
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| Endomyocardial biopsy device. |
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| Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. |
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| Cardiopulmonary bypass accessory equipment. |
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| Cardiopulmonary bypass bubble detector. |
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| Cardiopulmonary bypass vascular catheter, cannula, or tubing. |
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| Cardiopulmonary bypass heart-lung machine console. |
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| Cardiopulmonary bypass defoamer. |
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| Cardiopulmonary bypass heat exchanger. |
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| Cardiopulmonary bypass temperature controller. |
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| Cardiopulmonary bypass arterial line blood filter. |
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| Cardiopulmonary bypass cardiotomy suction line blood filter. |
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| Cardiopulmonary prebypass filter. |
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| Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. |
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| Cardiopulmonary bypass gas control unit. |
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| Cardiopulmonary bypass coronary pressure gauge. |
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| Cardiopulmonary bypass pulsatile flow generator. |
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| Cardiopulmonary bypass on-line blood gas monitor. |
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| Cardiopulmonary bypass level sensing monitor and/or control. |
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| Cardiopulmonary bypass oxygenator. |
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| Nonroller-type blood pump. |
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| Roller-type cardiopulmonary bypass blood pump. |
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| Cardiopulmonary bypass pump speed control. |
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| Cardiopulmonary bypass pump tubing. |
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| Cardiopulmonary bypass blood reservoir. |
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| Cardiopulmonary bypass in-line blood gas sensor. |
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| Cardiopulmonary bypass cardiotomy return sucker. |
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| Cardiopulmonary bypass intracardiac suction control. |
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| Cardiovascular surgical instruments. |
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| Intraluminal artery stripper. |
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Subpart F—CARDIOVASCULAR THERAPEUTIC DEVICES
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| Patient care suction apparatus. |
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| Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. |
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| External cardiac compressor. |
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| Cardiopulmonary resuscitation (CPR) aid. |
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| External counter-pulsating device. |
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| DC-defibrillator (including paddles). |
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| Automated external defibrillator system. |
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| External transcutaneous cardiac pacemaker (noninvasive). |
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| Steerable cardiac ablation catheter remote control system. |
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| Compressible limb sleeve. |
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| Thermal regulating system. |
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| Esophageal thermal regulation device. |
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| Automatic rotating tourniquet. |
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