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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 870--CARDIOVASCULAR DEVICES
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 | 870.1 | Scope. |
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| 870.3 | Effective dates of requirement for premarket approval. |
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| 870.9 | Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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| 870.1025 | Arrhythmia detector and alarm. |
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| 870.1100 | Blood pressure alarm. |
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| 870.1110 | Blood pressure computer. |
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| 870.1120 | Blood pressure cuff. |
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| 870.1130 | Noninvasive blood pressure measurement system. |
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| 870.1140 | Venous blood pressure manometer. |
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| 870.1200 | Diagnostic intravascular catheter. |
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| 870.1210 | Continuous flush catheter. |
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| 870.1220 | Electrode recording catheter or electrode recording probe. |
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| 870.1230 | Fiberoptic oximeter catheter. |
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| 870.1240 | Flow-directed catheter. |
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| 870.1250 | Percutaneous catheter. |
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| 870.1270 | Intracavitary phonocatheter system. |
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| 870.1280 | Steerable catheter. |
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| 870.1290 | Steerable catheter control system. |
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| 870.1300 | Catheter cannula. |
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| 870.1310 | Vessel dilator for percutaneous catheterization. |
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| 870.1330 | Catheter guide wire. |
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| 870.1340 | Catheter introducer. |
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| 870.1350 | Catheter balloon repair kit. |
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| 870.1360 | Trace microsphere. |
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| 870.1370 | Catheter tip occluder. |
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| 870.1380 | Catheter stylet. |
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| 870.1390 | Trocar. |
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| 870.1425 | Programmable diagnostic computer. |
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| 870.1435 | Single-function, preprogrammed diagnostic computer. |
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| 870.1450 | Densitometer. |
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| 870.1650 | Angiographic injector and syringe. |
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| 870.1660 | Indicator injector. |
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| 870.1670 | Syringe actuator for an injector. |
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| 870.1750 | External programmable pacemaker pulse generator. |
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| 870.1800 | Withdrawal-infusion pump. |
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| 870.1875 | Stethoscope. |
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| 870.1915 | Thermodilution probe. |
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| 870.2050 | Biopotential amplifier and signal conditioner. |
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| 870.2060 | Transducer signal amplifier and conditioner. |
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| 870.2100 | Cardiovascular blood flowmeter. |
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| 870.2120 | Extravascular blood flow probe. |
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| 870.2300 | Cardiac monitor (including cardiotachometer and rate alarm). |
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| 870.2310 | Apex cardiograph (vibrocardiograph). |
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| 870.2320 | Ballistocardiograph. |
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| 870.2330 | Echocardiograph. |
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| 870.2340 | Electrocardiograph. |
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| 870.2350 | Electrocardiograph lead switching adaptor. |
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| 870.2360 | Electrocardiograph electrode. |
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| 870.2370 | Electrocardiograph surface electrode tester. |
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| 870.2390 | Phonocardiograph. |
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| 870.2400 | Vectorcardiograph. |
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| 870.2450 | Medical cathode-ray tube display. |
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| 870.2600 | Signal isolation system. |
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| 870.2620 | Line isolation monitor. |
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| 870.2640 | Portable leakage current alarm. |
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| 870.2675 | Oscillometer. |
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| 870.2700 | Oximeter. |
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| 870.2710 | Ear oximeter. |
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| 870.2750 | Impedance phlebograph. |
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| 870.2770 | Impedance plethysmograph. |
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| 870.2780 | Hydraulic, pneumatic, or photoelectric plethysmographs. |
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| 870.2800 | Medical magnetic tape recorder. |
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| 870.2810 | Paper chart recorder. |
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| 870.2840 | Apex cardiographic transducer. |
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| 870.2850 | Extravascular blood pressure transducer. |
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| 870.2860 | Heart sound transducer. |
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| 870.2870 | Catheter tip pressure transducer. |
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| 870.2880 | Ultrasonic transducer. |
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| 870.2890 | Vessel occlusion transducer. |
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| 870.2900 | Patient transducer and electrode cable (including connector). |
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| 870.2910 | Radiofrequency physiological signal transmitter and receiver. |
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| 870.2920 | Telephone electrocardiograph transmitter and receiver. |
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| 870.3250 | Vascular clip. |
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| 870.3260 | Vena cava clip. |
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| 870.3300 | Arterial embolization device. |
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| 870.3375 | Cardiovascular intravascular filter. |
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| 870.3375 | Cardiovascular intravascular filter. |
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| 870.3450 | Vascular graft prosthesis of less than 6 millimeters diameter. |
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| 870.3460 | Vascular graft prosthesis of 6 millimeters and greater diameter. |
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| 870.3470 | Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
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| 870.3535 | Intra-aortic balloon and control system |
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| 870.3545 | Ventricular bypass (assist) device. |
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| 870.3600 | External pacemaker pulse generator. |
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| 870.3610 | Implantable pacemaker pulse generator. |
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| 870.3620 | Pacemaker lead adaptor. |
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| 870.3630 | Pacemaker generator function analyzer. |
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| 870.3640 | Indirect pacemaker generator function analyzer. |
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| 870.3650 | Pacemaker polymeric mesh bag. |
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| 870.3670 | Pacemaker charger. |
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| 870.3680 | Cardiovascular permanent or temporary pacemaker electrode. |
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| 870.3690 | Pacemaker test magnet. |
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| 870.3700 | Pacemaker programmers. |
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| 870.3710 | Pacemaker repair or replacement material. |
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| 870.3720 | Pacemaker electrode function tester. |
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| 870.3730 | Pacemaker service tools. |
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| 870.3800 | Annuloplasty ring. |
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| 870.3850 | Carotid sinus nerve stimulator. |
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| 870.3925 | Replacement heart valve. |
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| 870.3935 | Prosthetic heart valve holder. |
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| 870.3945 | Prosthetic heart valve sizer. |
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| 870.4075 | Endomyocardial biopsy device. |
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| 870.4200 | Cardiopulmonary bypass accessory equipment. |
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| 870.4205 | Cardiopulmonary bypass bubble detector. |
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| 870.4210 | Cardiopulmonary bypass vascular catheter, cannula, or tubing. |
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| 870.4220 | Cardiopulmonary bypass heart-lung machine console. |
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| 870.4230 | Cardiopulmonary bypass defoamer. |
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| 870.4240 | Cardiopulmonary bypass heat exchanger. |
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| 870.4250 | Cardiopulmonary bypass temperature controller. |
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| 870.4260 | Cardiopulmonary bypass arterial line blood filter. |
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| 870.4270 | Cardiopulmonary bypass cardiotomy suction line blood filter. |
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| 870.4280 | Cardiopulmonary prebypass filter. |
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| 870.4290 | Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. |
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| 870.4300 | Cardiopulmonary bypass gas control unit. |
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| 870.4310 | Cardiopulmonary bypass coronary pressure gauge. |
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| 870.4320 | Cardiopulmonary bypass pulsatile flow generator. |
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| 870.4330 | Cardiopulmonary bypass on-line blood gas monitor. |
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| 870.4340 | Cardiopulmonary bypass level sensing monitor and/or control. |
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| 870.4350 | Cardiopulmonary bypass oxygenator. |
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| 870.4360 | Nonroller-type cardiopulmonary bypass blood pump. |
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| 870.4370 | Roller-type cardiopulmonary bypass blood pump. |
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| 870.4380 | Cardiopulmonary bypass pump speed control. |
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| 870.4390 | Cardiopulmonary bypass pump tubing. |
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| 870.4400 | Cardiopulmonary bypass blood reservoir. |
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| 870.4410 | Cardiopulmonary bypass in-line blood gas sensor. |
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| 870.4420 | Cardiopulmonary bypass cardiotomy return sucker. |
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| 870.4430 | Cardiopulmonary bypass intracardiac suction control. |
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| 870.4450 | Vascular clamp. |
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| 870.4475 | Surgical vessel dilator. |
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| 870.4500 | Cardiovascular surgical instruments. |
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| 870.4875 | Intraluminal artery stripper. |
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| 870.4885 | External vein stripper. |
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| 870.5050 | Patient care suction apparatus. |
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| 870.5150 | Embolectomy catheter. |
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| 870.5175 | Septostomy catheter. |
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| 870.5200 | External cardiac compressor. |
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| 870.5225 | External counter-pulsating device. |
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| 870.5300 | DC-defribrillator (including paddles). |
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| 870.5325 | Defibrillator tester. |
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| 870.5550 | External transcutaneous cardiac pacemaker (noninvasive). |
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| 870.5550 | External transcutaneous cardiac pacemaker (noninvasive). |
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| 870.5800 | Compressible limb sleeve. |
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| 870.5900 | Thermal regulating system. |
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| 870.5925 | Automatic rotating tourniquet. |
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