21 CFR 870.3800
§ 870.3800 Annuloplasty ring.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.3800, § 870.3800 Annuloplasty ring, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89978
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Full text
(a) Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.
(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.