21 CFR § 870.4280 - Cardiopulmonary prebypass filter.

§ 870.4280 Cardiopulmonary prebypass filter.

(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).