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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Left Atrial Appendage Clip, Implantable
510(k) Number K254232
Device Name ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)
Applicant
Edwards Lifesciences
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Corinne Yestrepsky
Correspondent
Edwards Lifesciences
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Corinne Yestrepsky
Regulation Number878.4300
Classification Product Code
PZX  
Date Received12/29/2025
Decision Date 06/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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