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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 870Cardiovascular Devices870.1 – 870.5925
Subpart BCardiovascular Diagnostic Devices870.1025 – 870.1915
§ 870.1025Arrhythmia detector and alarm (including ST-segment measurement and alarm).
§ 870.1100Blood pressure alarm.
§ 870.1110Blood pressure computer.
§ 870.1120Blood pressure cuff.
§ 870.1130Noninvasive blood pressure measurement system.
§ 870.1140Venous blood pressure manometer.
§ 870.1200Diagnostic intravascular catheter.
§ 870.1210Continuous flush catheter.
§ 870.1220Electrode recording catheter or electrode recording probe.
§ 870.1230Fiberoptic oximeter catheter.
§ 870.1240Flow-directed catheter.
§ 870.1250Percutaneous catheter.
§ 870.1251Temporary catheter for embolic protection during transcatheter intracardiac procedures.
§ 870.1252Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
§ 870.1255Balloon aortic valvuloplasty catheter.
§ 870.1270Intracavitary phonocatheter system.
§ 870.1280Steerable catheter.
§ 870.1290Steerable catheter control system.
§ 870.1300Catheter cannula.
§ 870.1310Vessel dilator for percutaneous catheterization.
§ 870.1330Catheter guide wire.
§ 870.1340Catheter introducer.
§ 870.1342Reverse central venous recanalization system.
§ 870.1345Intravascular bleed monitor.
§ 870.1350Catheter balloon repair kit.
§ 870.1360Trace microsphere.
§ 870.1370Catheter tip occluder.
§ 870.1380Catheter stylet.
§ 870.1390Trocar.
§ 870.1405Interventional cardiovascular implant simulation software device.
§ 870.1415Coronary vascular physiologic simulation software device.
§ 870.1420Coronary artery disease risk indicator using acoustic heart signals.
§ 870.1425Programmable diagnostic computer.
§ 870.1435Single-function, preprogrammed diagnostic computer.
§ 870.1450Densitometer.
§ 870.1650Angiographic injector and syringe.
§ 870.1660Indicator injector.
§ 870.1670Syringe actuator for an injector.
§ 870.1750External programmable pacemaker pulse generator.
§ 870.1800Withdrawal-infusion pump.
§ 870.1875Stethoscope.
§ 870.1915Thermodilution probe.