---
kind: "section"
citation: "21 C.F.R. § 870.3800"
title: "21"
number: "870.3800"
heading: "Annuloplasty ring."
url: "https://uscodex.org/cfr/21/870.3800"
---

# §870.3800. Annuloplasty ring.

- (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.”

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001]