---
kind: "section"
citation: "21 C.F.R. § 878.3720"
title: "21"
number: "878.3720"
heading: "Tracheal prosthesis."
url: "https://uscodex.org/cfr/21/878.3720"
---

# §878.3720. Tracheal prosthesis.

- (a) **Identification.** The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.
- (b) **Classification.** Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

## Notes

### Amendments

[65 FR 17146, Mar. 31, 2000]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[65 FR 17146, Mar. 31, 2000]