K241888
- 510(k) number
- K241888
- Device name
- Single-use Balloon Dilatation Catheter
- Applicant
- Leo Medical Co., Ltd. CN
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2024-12-20
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K241888.pdf
Official FDA record: K241888
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.