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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K254279
Device Name Edwards eSheath+ introducer set
Applicant
Edwards Lifesciences
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Venkatesh Rane
Correspondent
Edwards Lifesciences
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Venkatesh Rane
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/30/2025
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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