1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 870 - CARDIOVASCULAR DEVICES
  6. Subpart E - Cardiovascular Surgical Devices
  7. 21 CFR § 870.4220
21 CFR § 870.4220
Cardiopulmonary bypass heart-lung machine console
June 25, 2020
CFR

(a) Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

(b) Classification. Class II (performance standards).

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§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing
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§ 870.4230 Cardiopulmonary bypass defoamer

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