21 CFR § 870.4240 - Cardiopulmonary bypass heat exchanger.

§ 870.4240 Cardiopulmonary bypass heat exchanger.

(a)Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

(b)Classification. Class II (performance standards).