21 CFR § 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).