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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Pressure, Catheter Tip
510(k) Number K142749
Device Name TruWave Disposable Pressure Transducer
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92641
Applicant Contact ANDREW S. MAZURKIEWICZ
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92641
Correspondent Contact ANDREW S. MAZURKIEWICZ
Regulation Number870.2870
Classification Product Code
DXO  
Date Received09/24/2014
Decision Date 01/18/2015
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
Recalls CDRH Recalls
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