21 CFR 870.4320
§ 870.4320 Cardiopulmonary bypass pulsatile flow generator.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.4320, § 870.4320 Cardiopulmonary bypass pulsatile flow generator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90000
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Full text
(a) Identification. A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.