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 § 870.4370
21 CFR § 870.4370
Roller-type cardiopulmonary bypass blood pump
June 25, 2020
CFR

(a) Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

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

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§ 870.4360 Nonroller-type blood pump
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§ 870.4380 Cardiopulmonary bypass pump speed control

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