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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K252445
Device Name Fusion Bioline Vascular Graft
Applicant
Maquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact Suwah Amara
Correspondent
Maquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Suwah Amara
Regulation Number870.3450
Classification Product Code
DSY  
Subsequent Product Code
DYF  
Date Received08/04/2025
Decision Date 04/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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