Code of Federal Regulations · Section
§ 870.4370 — Roller-type Cardiopulmonary Bypass Blood Pump
21 C.F.R. § 870.4370
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351