K254232

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)

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 CA · US
Product code: PZX — Left Atrial Appendage Clip, Implantable
Decision date: 2026-06-26
Date received: 2025-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K254232.pdf

Official FDA record: K254232

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.