510(k) K251313 · JOH Tube Tracheostomy And Tube Cuff
Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Ca
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Dec 29, 2025 |
| Received | Apr 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251313
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.