SDB — Tracheal Prosthesis With Cover Material Derived From Human Sources Class II
FDA product code SDB covers "Tracheal Prosthesis With Cover Material Derived From Human Sources", a Class II medical device regulated under 21 CFR 868.3721. Submissions are reviewed by the Anesthesiology panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SDB
- Device Class
- Class II
- Regulation Number
- 868.3721
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- Yes
Definition
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. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230087 | peytant solutions | AMStent® Tracheobronchial Covered Stent System | October 16, 2024 |