510(k) K241888
K241888 is an FDA 510(k) premarket notification submitted by Leo Medical Co., Ltd. for the device "Single-use Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Leo Medical Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2024
- Date Received
- June 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type