K251313
- 510(k) number
- K251313
- Device name
- 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 Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
- Applicant
- Covidien, LLC CO · US
- Product code
- JOH — Tube Tracheostomy And Tube Cuff
- Decision date
- 2025-12-29
- Date received
- 2025-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251313.pdf
Official FDA record: K251313
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.