K253832
- 510(k) number
- K253832
- Device name
- Dilation Balloon Catheter
- Applicant
- Mirco-Tech (Nanjing) Co., Ltd. CN
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2026-04-24
- Date received
- 2025-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253832.pdf
Official FDA record: K253832
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.