DeviceClearance

ECLIPTIS Left Atrial Appendage Exclusion System (4 models)— 510(k) K254232

Substantially Equivalent

Edwards Lifesciences

FDA 510(k) clearance K254232 for ECLIPTIS Left Atrial Appendage Exclusion System (4 models), Substantially Equivalent on 2026-06-26. Applicant: Edwards Lifesciences. Device class: 2.

Clearance details

Device name as filed
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
Product code
Code PZX
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PZX

product code PZX
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.