Title 21: Food and Drugs
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/ PART 870 - CARDIOVASCULAR DEVICES
/ Subpart E - Cardiovascular Surgical Devices / § 870.4230 Cardiopulmonary bypass defoamer.
§ 870.4230 Cardiopulmonary bypass defoamer.
(a) Identification. A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.
(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”