21 CFR § 870.4270 Cardiovascular Devices

§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.

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

⚠ 3 pending changes to Part 870

(a) Identification. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.

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

← § 870.4260 Cardiopulmonary bypass arterial line blood filter.§ 870.4280 Cardiopulmonary prebypass filter. →