21 CFR 870.4290
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.4290, § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89997
- Permanent ID
ys:prov:89997@1- SHA-256
0ee81422307b691845ab3e7bf026f436c73799c4382357356c16dd889dbfe9bf
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Full text
(a) Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.
(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.