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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K251715
Device Name FlowArt® Vial Access Device Vented
Applicant
Asset Medikal
Ikitelli Osb, 17. Cadde No:17
Istanbul,  TR 34480
Applicant Contact Ebru Sirali
Correspondent
Arazy Group Consultants, Inc.
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
LHI  
Date Received06/04/2025
Decision Date 10/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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