Cardiovascular Diagnostic Devices

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Cardiovascular Devices
  7. Cardiovascular Diagnostic Devices

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Section
870.1025

Arrhythmia detector and alarm (including ST-segment measurement and alarm).

Section
870.1100

Blood pressure alarm.

Section
870.1110

Blood pressure computer.

Section
870.1120

Blood pressure cuff.

Section
870.1130

Noninvasive blood pressure measurement system.

Section
870.1140

Venous blood pressure manometer.

Section
870.1200

Diagnostic intravascular catheter.

Section
870.1210

Continuous flush catheter.

Section
870.1220

Electrode recording catheter or electrode recording probe.

Section
870.1230

Fiberoptic oximeter catheter.

Section
870.1240

Flow-directed catheter.

Section
870.1250

Percutaneous catheter.

Section
870.1251

Temporary catheter for embolic protection during transcatheter intracardiac procedures.

Section
870.1252

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.

Section
870.1255

Balloon aortic valvuloplasty catheter.

Section
870.1270

Intracavitary phonocatheter system.

Section
870.1280

Steerable catheter.

Section
870.1290

Steerable catheter control system.

Section
870.1300

Catheter cannula.

Section
870.1310

Vessel dilator for percutaneous catheterization.

Section
870.1330

Catheter guide wire.

Section
870.1340

Catheter introducer.

Section
870.1350

Catheter balloon repair kit.

Section
870.1360

Trace microsphere.

Section
870.1370

Catheter tip occluder.

Section
870.1380

Catheter stylet.

Section
870.1390

Trocar.

Section
870.1415

Coronary vascular physiologic simulation software device.

Section
870.1425

Programmable diagnostic computer.

Section
870.1435

Single-function, preprogrammed diagnostic computer.

Section
870.1450

Densitometer.

Section
870.1650

Angiographic injector and syringe.

Section
870.1660

Indicator injector.

Section
870.1670

Syringe actuator for an injector.

Section
870.1750

External programmable pacemaker pulse generator.

Section
870.1800

Withdrawal-infusion pump.

Section
870.1875

Stethoscope.

Section
870.1915

Thermodilution probe.