21 C.F.R. § 870.4370
Roller-type cardiopulmonary bypass blood pump.
Cite as 21 C.F.R. § 870.4370 (2026)
(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).