510(k) K243785 · BTR Tube, Tracheal (W/Wo Connector)
Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Dec 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243785
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.