21 C.F.R. § 870.4270

Current through November 30, 2024
Section 870.4270 - Cardiopulmonary bypass cardiotomy suction line blood filter
(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).

21 C.F.R. § 870.4270