K213969 is an FDA 510(k) clearance for the VisionAir Patient-Specific Airway Stent. This device is classified as a Prosthesis, Tracheal, Preformed/molded (Class II - Special Controls, product code NWA).
Submitted by New Cos Inc. Dba Visionair Solutions (Cleveland, US). The FDA issued a Cleared decision on October 7, 2022, 291 days after receiving the submission on December 20, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720. The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls..
| 510(k) Number | K213969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2021 |
| Decision Date | October 07, 2022 |
| Days to Decision | 291 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NWA - Prosthesis, Tracheal, Preformed/molded |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |
| Definition | The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls. |