Cardiovascular Surgical 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 Surgical Devices

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Section
870.4075

Endomyocardial biopsy device.

Section
870.4100

Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.

Section
870.4200

Cardiopulmonary bypass accessory equipment.

Section
870.4205

Cardiopulmonary bypass bubble detector.

Section
870.4210

Cardiopulmonary bypass vascular catheter, cannula, or tubing.

Section
870.4220

Cardiopulmonary bypass heart-lung machine console.

Section
870.4230

Cardiopulmonary bypass defoamer.

Section
870.4240

Cardiopulmonary bypass heat exchanger.

Section
870.4250

Cardiopulmonary bypass temperature controller.

Section
870.4260

Cardiopulmonary bypass arterial line blood filter.

Section
870.4270

Cardiopulmonary bypass cardiotomy suction line blood filter.

Section
870.4280

Cardiopulmonary prebypass filter.

Section
870.4290

Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

Section
870.4300

Cardiopulmonary bypass gas control unit.

Section
870.4310

Cardiopulmonary bypass coronary pressure gauge.

Section
870.4320

Cardiopulmonary bypass pulsatile flow generator.

Section
870.4330

Cardiopulmonary bypass on-line blood gas monitor.

Section
870.4340

Cardiopulmonary bypass level sensing monitor and/or control.

Section
870.4350

Cardiopulmonary bypass oxygenator.

Section
870.4360

Nonroller-type blood pump.

Section
870.4370

Roller-type cardiopulmonary bypass blood pump.

Section
870.4380

Cardiopulmonary bypass pump speed control.

Section
870.4390

Cardiopulmonary bypass pump tubing.

Section
870.4400

Cardiopulmonary bypass blood reservoir.

Section
870.4410

Cardiopulmonary bypass in-line blood gas sensor.

Section
870.4420

Cardiopulmonary bypass cardiotomy return sucker.

Section
870.4430

Cardiopulmonary bypass intracardiac suction control.

Section
870.4450

Vascular clamp.

Section
870.4475

Surgical vessel dilator.

Section
870.4500

Cardiovascular surgical instruments.

Section
870.4510

Apical closure device.

Section
870.4875

Intraluminal artery stripper.

Section
870.4885

External vein stripper.