21 C.F.R. § 870.4240 Cardiopulmonary bypass heat exchanger.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4240 Cardiopulmonary bypass heat exchanger.
