K243785
- 510(k) number
- K243785
- Device name
- 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 Tracheal Tube Cuffless Reinforced
- Applicant
- Covidien, LLC CO · US
- Product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Decision date
- 2025-09-25
- Date received
- 2024-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243785.pdf
Official FDA record: K243785
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.