(a) Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.
(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled ``Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.'' [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001]