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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 K123714
Device Name EDWARDS EMBOL-X INTRODUCER SHEATH
Applicant
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact LUKE MEIDELL
Correspondent
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact LUKE MEIDELL
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/04/2012
Decision Date 07/24/2013
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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