§ 870.4270. Cardiopulmonary bypass cardiotomy suction line blood filter.
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/us/cfr/t21/s§ 870.4270·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).