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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene
510(k) Number K141206
Device Name EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
Applicant
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact Nina Brooke
Correspondent
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact Nina Brooke
Regulation Number878.5010
Classification Product Code
GAW  
Subsequent Product Code
HCF  
Date Received05/09/2014
Decision Date 01/16/2015
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
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