510(k) K150844 ยท JOH Tube Tracheostomy And Tube Cuff
Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Jul 14, 2015 |
| Received | Mar 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150844
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2025 | Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R Open, Classified |
JOH | None listed |
| Apr 19, 2023 | Covidien Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless:
Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description):
10CN10H, 10.0MM SHILEY CUFFED TRACH CAN;
10CN Open, Classified |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.