DEN230087 is an FDA 510(k) submission for the AMStent® Tracheobronchial Covered Stent System. This device is classified as a Tracheal Prosthesis With Cover Material Derived From Human Sources (Class II - Special Controls, product code SDB).
Submitted by Peytant Solutions, Inc. (Plymouth, US). The FDA issued a Not Cleared (DENG) decision on October 16, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.3721. 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) Number | DEN230087 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 20, 2023 |
| Decision Date | October 16, 2024 |
| Days to Decision | 301 days |
| Submission Type | Direct |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | SDB - Tracheal Prosthesis With Cover Material Derived From Human Sources |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.3721 |
| 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. |