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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 K052964
Device Name EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
Applicant
Boston Scientific Corp
Two Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact KATIE GERBENSKY
Correspondent
Boston Scientific Corp
Two Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact KATIE GERBENSKY
Regulation Number870.3450
Classification Product Code
DSY  
Date Received10/21/2005
Decision Date 01/06/2006
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
Recalls CDRH Recalls
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