SDB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tracheal Prosthesis With Cover Material Derived From Human Sources
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.3721
- Medical specialty
- Anesthesiology
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMStent® Tracheobronchial Covered Stent System (DEN230087) | Peytant Solutions, Inc. | 2024-10-16 |
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