FDA 21 CFR Part 870 Cardiovascular Devices

FDA 21 CFR Part 870 Cardiovascular Devices

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Table of contents

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.

870.1255 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.

870.1350 Catheter balloon repair kit.

870.1360 Trace microsphere.

870.1370 Catheter tip occluder.

870.1380 Catheter stylet.

870.1390 Trocar.

870.1415 Coronary vascular physiologic simulation software device.

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

Subpart D - Cardiovascular Prosthetic Devices

Subpart E - Cardiovascular Surgical Devices, (and)

Subpart F - Cardiovascular Therapeutic Devices

FDA 21 CFR Part 870 Cardiovascular Devices:

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