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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 K103347
Device Name CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
Applicant
Intervascular Sas
Zone Industrielle Athelia I
La Ciotat,  FR 13705
Applicant Contact PHILIPPE BENSIMON
Correspondent
Intervascular Sas
Zone Industrielle Athelia I
La Ciotat,  FR 13705
Correspondent Contact PHILIPPE BENSIMON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/15/2010
Decision Date 02/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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