21 CFR 870.4420
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4420, § 870.4420 Cardiopulmonary bypass cardiotomy return sucker, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90010
- Permanent ID
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Full text
(a) Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.
(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.