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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K112694
Device Name EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
Applicant
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact SPENCER WALKER
Correspondent
Edwards Lifesciences, LLC
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact SPENCER WALKER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/15/2011
Decision Date 10/14/2011
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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