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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ligature Passing And Knot Tying
510(k) Number K150882
Device Name Edwards Suture Fastening System
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact NINA BROOKE
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact NINA BROOKE
Regulation Number878.4800
Classification Product Code
HCF  
Date Received04/02/2015
Decision Date 06/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
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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