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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 K141495
Device Name TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact ANDREW S MAZURKIEWICZ, JR
Correspondent
Edwards Lifesciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact ANDREW S MAZURKIEWICZ, JR
Regulation Number870.2870
Classification Product Code
DXO  
Date Received06/06/2014
Decision Date 09/03/2014
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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