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Electronic Code of Federal Regulations

e-CFR data is current as of February 13, 2020

Title 21Chapter ISubchapter HPart 870Subpart E → §870.4370


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


§870.4370   Roller-type cardiopulmonary bypass blood pump.

(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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