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510(k) K212370

Leaderflex Mini and Leaderflex Nano by Vygon USA — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2022
Date Received
July 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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