K240464
- 510(k) number
- K240464
- Device name
- WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- Applicant
- Boston Scientific MA · US
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2024-08-30
- Date received
- 2024-02-16
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240464.pdf
Official FDA record: K240464
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.