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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K221473
Device Name Flowart
Applicant
Asset Medikal Tasarim As.
Ikitelli Osb Mahallesi, 17. Cadde, No: 17, Basaksehir
Istanbul,  TR 34490
Applicant Contact Ebru Sirali
Correspondent
Licensale, Inc.
3422 Leonardo Ln.
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/20/2022
Decision Date 09/26/2022
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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