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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K212370
Device Name Leaderflex Mini and Leaderflex Nano
Applicant
Vygon USA
2750 Morris Rd Suite A200
Lansdale,  PA  19446
Applicant Contact Lauren Doyle
Correspondent
Vygon USA
2750 Morris Rd Suite A200
Lansdale,  PA  19446
Correspondent Contact Jay Wigley
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/30/2021
Decision Date 08/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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