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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 K183413
Device Name TruWave Disposable Pressure Transducer
Applicant
Edwards Lifeciences, LLC
One Edwards Way
Irvine,  CA  92614
Applicant Contact Ye Seul Kim
Correspondent
Edwards Lifeciences, LLC
One Edwards Way
Irvine,  CA  92614
Correspondent Contact Ye Seul Kim
Regulation Number870.2870
Classification Product Code
DXO  
Date Received12/10/2018
Decision Date 05/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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