De Novo DEN230087
- Device
- AMStent® Tracheobronchial Covered Stent System
- Contact
- john schorgl
- De Novo number
- DEN230087
- Product code
- SDB
- Regulation
- 868.3721
- Classification name
- tracheal prosthesis with cover material derived from human sources
- Decision
- granted (DENG)
- Decision date
- 2024-10-16
- Date received
- 2023-12-20
- Classification advisory
- Anesthesiology
- Review advisory
- Anesthesiology
- Type
- Direct
Current FDA Classification#
- Product code
- SDB
- Device name
- Tracheal Prosthesis With Cover Material Derived From Human Sources
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation
- 868.3721
- Implant
- Y
- Life sustain/support
- N