Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart D](/submissions/AN/subpart-d%E2%80%94) → [21 CFR 868.3721](/submissions/AN/subpart-d%E2%80%94/868.3721) → SDB — Tracheal Prosthesis With Cover Material Derived From Human Sources

# SDB · Tracheal Prosthesis With Cover Material Derived From Human Sources

_Anesthesiology · 21 CFR 868.3721 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-d%E2%80%94/SDB

## Overview

- **Product Code:** SDB
- **Device Name:** Tracheal Prosthesis With Cover Material Derived From Human Sources
- **Regulation:** [21 CFR 868.3721](/submissions/AN/subpart-d%E2%80%94/868.3721)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **Implant:** yes

## Identification

The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. The AMStent® Tracheobronchial Covered Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms in adult patients.

## Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated using general controls and the identified special controls.

## Special Controls

In combination with the general controls of the FD&C Act. the tracheal prosthesis with cover material derived from human sourcesis subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230087](https://fda.innolitics.com/submissions/AN/subpart-d%E2%80%94/SDB/DEN230087.md) | AMStent® Tracheobronchial Covered Stent System | Peytant Solutions, Inc. | Oct 16, 2024 | DENG |

## Top Applicants

- Peytant Solutions, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-d%E2%80%94/SDB](https://fda.innolitics.com/submissions/AN/subpart-d%E2%80%94/SDB)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com