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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 K022242
Device Name INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
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 Received07/11/2002
Decision Date 08/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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