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510(k) K241888

Single-use Balloon Dilatation Catheter by Leo Medical Co., Ltd. — Product Code FGE

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

Other clearances by Leo Medical Co., Ltd.

  • K172985 — Ligation Device (June 14, 2018)

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