CFR /  Title 21  /  Part 870: Cardiovascular Devices

Section No.	Description
Section 870.1	Effective dates of requirement for premarket approval
Section 870.3	Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
Section 870.9	Arrhythmia detector and alarm (including ST-segment measurement and alarm)
Section 870.1025	Blood pressure alarm
Section 870.1100	Blood pressure computer
Section 870.1110	Blood pressure cuff
Section 870.1120	Noninvasive blood pressure measurement system
Section 870.1130	Venous blood pressure manometer
Section 870.1140	Diagnostic intravascular catheter
Section 870.1200	Continuous flush catheter
Section 870.1210	Electrode recording catheter or electrode recording probe
Section 870.1220	Fiberoptic oximeter catheter
Section 870.1230	Flow-directed catheter
Section 870.1240	Percutaneous catheter
Section 870.1250	Intracavitary phonocatheter system
Section 870.1270	Steerable catheter
Section 870.1280	Steerable catheter control system
Section 870.1290	Catheter cannula
Section 870.1300	Vessel dilator for percutaneous catheterization
Section 870.1310	Catheter guide wire
Section 870.1330	Catheter introducer
Section 870.1340	Catheter balloon repair kit
Section 870.1350	Trace microsphere
Section 870.1360	Catheter tip occluder
Section 870.1370	Catheter stylet
Section 870.1380	Trocar
Section 870.1390	Programmable diagnostic computer
Section 870.1425	Single-function, preprogrammed diagnostic computer
Section 870.1435	Densitometer
Section 870.1450	Angiographic injector and syringe
Section 870.1650	Indicator injector
Section 870.1660	Syringe actuator for an injector
Section 870.1670	External programmable pacemaker pulse generator
Section 870.1750	Withdrawal-infusion pump
Section 870.1800	Stethoscope
Section 870.1875	Thermodilution probe
Section 870.1915	Biopotential amplifier and signal conditioner
Section 870.2050	Transducer signal amplifier and conditioner
Section 870.2060	Cardiovascular blood flowmeter
Section 870.2100	Extravascular blood flow probe
Section 870.2120	Cardiac monitor (including cardiotachometer and rate alarm)
Section 870.2300	Apex cardiograph (vibrocardiograph)
Section 870.2310	Ballistocardiograph
Section 870.2320	Echocardiograph
Section 870.2330	Electrocardiograph
Section 870.2340	Electrocardiograph lead switching adaptor
Section 870.2350	Electrocardiograph electrode
Section 870.2360	Electrocardiograph surface electrode tester
Section 870.2370	Phonocardiograph
Section 870.2390	Vectorcardiograph
Section 870.2400	Medical cathode-ray tube display
Section 870.2450	Signal isolation system
Section 870.2600	Line isolation monitor
Section 870.2620	Portable leakage current alarm
Section 870.2640	Oscillometer
Section 870.2675	Oximeter
Section 870.2700	Ear oximeter
Section 870.2710	Impedance phlebograph
Section 870.2750	Impedance plethysmograph
Section 870.2770	Hydraulic, pneumatic, or photoelectric plethysmographs
Section 870.2780	Medical magnetic tape recorder
Section 870.2800	Paper chart recorder
Section 870.2810	Apex cardiographic transducer
Section 870.2840	Extravascular blood pressure transducer
Section 870.2850	Implantable Intra-aneurysm Pressure Measurement System
Section 870.2855	Heart sound transducer
Section 870.2860	Catheter tip pressure transducer
Section 870.2870	Ultrasonic transducer
Section 870.2880	Vessel occlusion transducer
Section 870.2890	Patient transducer and electrode cable (including connector)
Section 870.2900	Radiofrequency physiological signal transmitter and receiver
Section 870.2910	Telephone electrocardiograph transmitter and receiver
Section 870.2920	Vascular clip
Section 870.3250	Vena cava clip
Section 870.3260	Vascular embolization device
Section 870.3300	Cardiovascular intravascular filter
Section 870.3375	Vascular graft prosthesis
Section 870.3450	Endovascular Suturing System
Section 870.3460	Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
Section 870.3470	Intra-aortic balloon and control system
Section 870.3535	Ventricular bypass (assist) device
Section 870.3545	External pacemaker pulse generator
Section 870.3600	Implantable pacemaker pulse generator
Section 870.3610	Pacemaker lead adaptor
Section 870.3620	Pacemaker generator function analyzer
Section 870.3630	Indirect pacemaker generator function analyzer
Section 870.3640	Pacemaker polymeric mesh bag
Section 870.3650	Pacemaker charger
Section 870.3670	Cardiovascular permanent or temporary pacemaker electrode
Section 870.3680	Pacemaker test magnet
Section 870.3690	Pacemaker programmers
Section 870.3700	Pacemaker repair or replacement material
Section 870.3710	Pacemaker electrode function tester
Section 870.3720	Pacemaker service tools
Section 870.3730	Annuloplasty ring
Section 870.3800	Carotid sinus nerve stimulator
Section 870.3850	Replacement heart valve
Section 870.3925	Prosthetic heart valve holder
Section 870.3935	Prosthetic heart valve sizer
Section 870.3945	Endomyocardial biopsy device
Section 870.4075	Cardiopulmonary bypass accessory equipment
Section 870.4200	Cardiopulmonary bypass bubble detector
Section 870.4205	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Section 870.4210	Cardiopulmonary bypass heart-lung machine console
Section 870.4220	Cardiopulmonary bypass defoamer
Section 870.4230	Cardiopulmonary bypass heat exchanger
Section 870.4240	Cardiopulmonary bypass temperature controller
Section 870.4250	Cardiopulmonary bypass arterial line blood filter
Section 870.4260	Cardiopulmonary bypass cardiotomy suction line blood filter
Section 870.4270	Cardiopulmonary prebypass filter
Section 870.4280	Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting
Section 870.4290	Cardiopulmonary bypass gas control unit
Section 870.4300	Cardiopulmonary bypass coronary pressure gauge
Section 870.4310	Cardiopulmonary bypass pulsatile flow generator
Section 870.4320	Cardiopulmonary bypass on-line blood gas monitor
Section 870.4330	Cardiopulmonary bypass level sensing monitor and/or control
Section 870.4340	Cardiopulmonary bypass oxygenator
Section 870.4350	Nonroller-type cardiopulmonary bypass blood pump
Section 870.4360	Roller-type cardiopulmonary bypass blood pump
Section 870.4370	Cardiopulmonary bypass pump speed control
Section 870.4380	Cardiopulmonary bypass pump tubing
Section 870.4390	Cardiopulmonary bypass blood reservoir
Section 870.4400	Cardiopulmonary bypass in-line blood gas sensor
Section 870.4410	Cardiopulmonary bypass cardiotomy return sucker
Section 870.4420	Cardiopulmonary bypass intracardiac suction control
Section 870.4430	Vascular clamp
Section 870.4450	Surgical vessel dilator
Section 870.4475	Cardiovascular surgical instruments
Section 870.4500	Intraluminal artery stripper
Section 870.4875	External vein stripper
Section 870.4885	Patient care suction apparatus
Section 870.5050	Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Section 870.5100	Embolectomy catheter
Section 870.5150	Septostomy catheter
Section 870.5175	External cardiac compressor
Section 870.5200	External counter-pulsating device
Section 870.5225	DC-defibrillator (including paddles)
Section 870.5300	Automated external defibrillator system
Section 870.5310	Defibrillator tester
Section 870.5325	External transcutaneous cardiac pacemaker (noninvasive)
Section 870.5550	Compressible limb sleeve
Section 870.5800	Thermal regulating system
Section 870.5900	Automatic rotating tourniquet
Section 870.5925	Scope