21 CFR § 870.4300 Cardiovascular Devices

§ 870.4300 Cardiopulmonary bypass gas control unit.

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

⚠ 3 pending changes to Part 870

(a) Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

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

← § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.§ 870.4310 Cardiopulmonary bypass coronary pressure gauge. →