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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 K163693
Device Name IntraClude Intra-Aortic Occlusion Device
Applicant
Edwards Lifesciences LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Lisa G. Hessabi
Correspondent
Edwards Lifesciences LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Lisa G. Hessabi
Regulation Number870.4450
Classification Product Code
DXC  
Date Received12/28/2016
Decision Date 01/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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