 |
Code of Federal Regulations (Last Updated: November 8, 2024) |
 |
Title 21 - Food and Drugs |
|
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
|
SubChapter H - Medical Devices |
|
|
Part 870 - Cardiovascular Devices |
| 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). |
| 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. |
| § 870.1251 - 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. |
| 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. |
| § 870.2200 - 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. |
| § 870.2390 - 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. |
| § 870.2785 - 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. |
| 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. |
| § 870.3605 - 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. |
| Subpart E - Cardiovascular Surgical Devices |
| § 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. |
| § 870.4875 - Intraluminal artery stripper. |
| § 870.4885 - External vein stripper. |
| 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. |
| § 870.5210 - 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. |
| § 870.5800 - Compressible limb sleeve. |
| § 870.5900 - Thermal regulating system. |
| § 870.5910 - Esophageal thermal regulation device. |
| § 870.5925 - Automatic rotating tourniquet. |