K233341
- 510(k) number
- K233341
- Device name
- Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
- Applicant
- Covidien, LLC CO · US
- Product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Decision date
- 2024-05-20
- Date received
- 2023-09-29
- 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: K233341.pdf
Official FDA record: K233341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.