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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 K131778
Device Name FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
Applicant
MAQUET CARDIOVASCULAR LLC
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact MARYLOU INSINGA
Correspondent
MAQUET CARDIOVASCULAR LLC
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact MARYLOU INSINGA
Regulation Number870.3450
Classification Product Code
DSY  
Date Received06/17/2013
Decision Date 11/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01113892
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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