21 CFR 870.4430
§ 870.4430 Cardiopulmonary bypass intracardiac suction control.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4430, § 870.4430 Cardiopulmonary bypass intracardiac suction control, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90011
- Permanent ID
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Full text
(a) Identification. A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker.
(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.