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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K230579
Device Name Smart Wedge algorithm
Applicant
Edwards Lifesciences, LLC
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Jennifer Wilbur
Correspondent
Edwards Lifesciences, LLC
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Jennifer Wilbur
Regulation Number870.1425
Classification Product Code
DQK  
Date Received03/02/2023
Decision Date 08/18/2023
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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