510(k) K250173 · BTR Tube, Tracheal (W/Wo Connector)
Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with Taper
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Oct 6, 2025 |
| Received | Jan 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250173
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.