AMStent® Tracheobronchial Covered Stent System
FDA 510(k) clearance DEN230087 · decided 2024-10-16
Clearance details
- K-number
- DEN230087
- Device name
- AMStent® Tracheobronchial Covered Stent System
- Applicant
- Peytant Solutions, Inc.
- Decision
- Unknown
- Date received
- 2023-12-20
- Decision date
- 2024-10-16
- Days to decision
- 301 days
- Clearance type
- Direct
- Product code
- SDB
- Device class
- 2
- Regulation number
- 868.3721
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.