Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3720](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3720) → NYT — Prosthesis, Tracheal, Expandable, Polymeric

# NYT · Prosthesis, Tracheal, Expandable, Polymeric

_General, Plastic Surgery · 21 CFR 878.3720 · Class 2_

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

## Overview

- **Product Code:** NYT
- **Device Name:** Prosthesis, Tracheal, Expandable, Polymeric
- **Regulation:** [21 CFR 878.3720](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3720)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## 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.

## Classification Rationale

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

## Special Controls

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

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K013266](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NYT/K013266.md) | RUSCH POLYFLEX STENT KIT | Rusch Intl. | Nov 27, 2001 | SESE |
| [K982614](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NYT/K982614.md) | RUSCH POLYFLEX STENT KIT | Rusch Intl. | Dec 4, 1998 | SESE |
| [K953593](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/NYT/K953593.md) | RUSCH TRACHEAL BRONCHIAL Y STENT | Rusch, Inc. | Oct 13, 1995 | ST |

## Top Applicants

- Rusch Intl. — 2 clearances
- Rusch, Inc. — 1 clearance

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

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