510(k) K213969 ยท NWA Prosthesis, Tracheal, Preformed/Molded
VisionAir Patient-Specific Airway Stent
| Applicant | New Cos Inc. Dba Visionair Solutions, Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 7, 2022 |
| Received | Dec 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213969
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.