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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intracardiac Patch Or Pledget, Biologically Derived
510(k) Number K172660
Device Name Duravess bovine pericardial vascular patch
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Christine Chun
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Christine Chun
Regulation Number870.3470
Classification Product Code
PSQ  
Date Received09/05/2017
Decision Date 11/17/2017
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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