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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
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