Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart E - Cardiovascular Surgical Devices / § 870.4370 Roller-type cardiopulmonary bypass blood pump.
§ 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).