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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K042984
Device Name INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
Original Applicant
INTERVASCULAR
690 canton street
suite 302
westwood,  MA  02090
Original Contact amy aulwes
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/29/2004
Decision Date 02/18/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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