DEN230087
- 510(k) number
- DEN230087
- Device name
- AMStent® Tracheobronchial Covered Stent System
- Applicant
- Peytant Solutions, Inc. MN · US
- Product code
- SDB — Tracheal Prosthesis With Cover Material Derived From
- Decision date
- 2024-10-16
- Date received
- 2023-12-20
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Anesthesiology
Official FDA record: DEN230087
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.