← Product Code [JCT](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT) · K071604

# ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM (K071604)

_Alveolus, Inc. · JCT · Sep 19, 2007 · General, Plastic Surgery · SESU_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K071604

## Device Facts

- **Applicant:** Alveolus, Inc.
- **Product Code:** [JCT](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT.md)
- **Decision Date:** Sep 19, 2007
- **Decision:** SESU
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3720
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

## Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K071604](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/JCT/K071604)

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