Code of Federal Regulations · Section

§ 870.4370 — Roller-type Cardiopulmonary Bypass Blood Pump

21 C.F.R. § 870.4370

View:

(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