510(k) K213969
K213969 is an FDA 510(k) premarket notification submitted by New Cos Inc. Dba Visionair Solutions for the device "VisionAir Patient-Specific Airway Stent". The FDA issued a decision of Substantially Equivalent on October 7, 2022. The device falls under product code NWA (Prosthesis, Tracheal, Preformed/Molded), a Class II device regulated under 21 CFR 878.3720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2022
- Date Received
- December 20, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Preformed/Molded
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type
The device is intended to provide support to weakened or constricting airway walls.