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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K162184
Device Name Edwards eSheath Introducer Set
Applicant
Edward Lifesciences
1 Edward Way
Irvine,  CA  92614
Applicant Contact Yi Gao
Correspondent
Edward Lifesciences
1 Edward Way
Irvine,  CA  92614
Correspondent Contact Yi Gao
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/04/2016
Decision Date 09/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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