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Electronic Code of Federal Regulations

e-CFR data is current as of April 8, 2020

Title 21Chapter ISubchapter HPart 870Subpart E → §870.4380


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices


§870.4380   Cardiopulmonary bypass pump speed control.

(a) Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

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

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