21 C.F.R. § 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
