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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K242255
Device Name Qitexio® 4-Way Stopcock (QIT014)
Applicant
Medex
240 Allee Jacques Monod
Saint-Priest,  FR 69800
Applicant Contact Guylaine Casses
Correspondent
Guerbet, LLC
214 Carnegie Center, Suite 300
Princeton,  NJ  08540
Correspondent Contact Haewon Park
Regulation Number880.5440
Classification Product Code
FMG  
Date Received07/31/2024
Decision Date 04/29/2025
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
Predetermined Change
Control Plan Authorized		 No
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