NYT · Prosthesis, Tracheal, Expandable, Polymeric
General, Plastic Surgery · 21 CFR 878.3720 · Class 2
Overview
| Product Code | NYT |
|---|---|
| Device Name | Prosthesis, Tracheal, Expandable, Polymeric |
| Regulation | 21 CFR 878.3720 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | RUSCH POLYFLEX STENT KIT | Rusch Intl. | Nov 27, 2001 | SESE |
| K982614 | RUSCH POLYFLEX STENT KIT | Rusch Intl. | Dec 4, 1998 | SESE |
| K953593 | RUSCH TRACHEAL BRONCHIAL Y STENT | Rusch, Inc. | Oct 13, 1995 | ST |
Top Applicants
- Rusch Intl. — 2 clearances
- Rusch, Inc. — 1 clearance
