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e-CFR data is current as of July 13, 2020

Title 21Chapter ISubchapter HPart 870Subpart E → §870.4270


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices


§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).

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