21 C.F.R. § 870.4370

Roller-type cardiopulmonary bypass blood pump.

Last amended: 2016Year: 2026Length: 35 wordsSubsections: 1Official source

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).
21 C.F.R. § 870.4370: Roller-type cardiopulmonary bypass blood pump. | Justis AI