21 CFR 870.4240
§ 870.4240 Cardiopulmonary bypass heat exchanger.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4240, § 870.4240 Cardiopulmonary bypass heat exchanger, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89992
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Full text
(a) Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
(b) Classification. Class II (performance standards).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.