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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K032587
Device Name EDWARDS PERIPHERAL DILATATION CATHETER
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact KEVIN DRISKO
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact KEVIN DRISKO
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/22/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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