Cardiovascular Diagnostic Devices | Midpage

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Code of Federal Regulations

Subpart B

Cardiovascular Diagnostic Devices

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.