21 C.F.R. § 870.4280 Cardiopulmonary prebypass filter.
Title 21 - Food and Drugs
(a) Identification. A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart E—Cardiovascular Surgical Devices
§ 870.4280 Cardiopulmonary prebypass filter.
