K232245
- 510(k) number
- K232245
- Device name
- VedDilator ^TM (3-Stage Balloon Dilation Catheter)
- Applicant
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. CN
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2024-02-15
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232245.pdf
Official FDA record: K232245
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.