510(k) DEN230087
- Device
- AMStent® Tracheobronchial Covered Stent System
- Applicant
- Peytant Solutions, Inc.
- 510(k) number
- DEN230087
- Product code
- SDB
- Decision
- Unknown (DENG)
- Decision date
- 2024-10-16
- Date received
- 2023-12-20
- Regulation
- 868.3721
- Classification name
- Tracheal Prosthesis With Cover Material Derived From Human Sources
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- John Schorgl
- Address
- 3650 Annapolis Ln. N., #180 Plymouth MN US 55447 55447
FDA Registration Numbers#
- 3013847376
Source Documents#
510(k) summary PDF not indicated by FDA