21 CFR 870.4280
§ 870.4280 Cardiopulmonary prebypass filter.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4280, § 870.4280 Cardiopulmonary prebypass filter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89996
- Permanent ID
ys:prov:89996@1- SHA-256
8ec74583b9064bd3d0852f72127feb2230a545b96c0caa1f9641822dacf02281
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Full text
(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 (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.