Tracheal Prosthesis With Cover Material Derived From Human Sources
A tracheal prosthesis with cover material derived from human sources is an expandable tubular metal implant covered with a human-sourced decellularized material, intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree; it may include a delivery system and does not include products intended to promote regeneration, impede inflammation, or release growth factors. It is classified as FDA Class II (510(k) required) under regulation 868.3721 in the Anesthesiology specialty, with product code SDB. The device is flagged as an implant, reflecting permanent placement, but does not support life-sustaining functions independently.
Basic Information
- Product Code
- SDB
- Device Class
- FDA class 2
- Regulation Number
- 868.3721
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230087 | AMStent® Tracheobronchial Covered Stent System | Oct 16, 2024 | Unknown | Peytant Solutions, Inc. |