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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 K013651
Device Name INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
Applicant
Intervascular
20 Walnut St.; Suite 12
Wellesley,  MA  02481
Applicant Contact Amy Aulwes
Correspondent
Intervascular
20 Walnut St.; Suite 12
Wellesley,  MA  02481
Correspondent Contact Amy Aulwes
Regulation Number870.3450
Classification Product Code
DSY  
Date Received11/06/2001
Decision Date 02/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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