21 CFR 870.4270
§ 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4270, § 870.4270 Cardiopulmonary bypass cardiotomy suction line blood filter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89995
- Permanent ID
ys:prov:89995@1- SHA-256
75fed8944fa61f3fb5896459929a056041db0bac5260dcc3006a983f751ca18d
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Full text
(a) Identification. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
(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.