§ 870.4350. Cardiopulmonary bypass oxygenator.
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/us/cfr/t21/s§ 870.4350·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.
(b)Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.” [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001]
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§ 870.4350
Cardiopulmonary bypass oxygenator.
Fed. Reg.×2
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