21 CFR § 870.4240 Cardiovascular Devices

§ 870.4240 Cardiopulmonary bypass heat exchanger.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.4230 Cardiopulmonary bypass defoamer.§ 870.4250 Cardiopulmonary bypass temperature controller. →