ECLIPTIS Left Atrial Appendage Exclusion System (4 models)— 510(k) K254232
Substantially EquivalentEdwards 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.
Summary
Edwards Lifesciences' clearance covers the ECLIPTIS Left Atrial Appendage Exclusion System in four models: ECS135, ECS140, ECS145, and ECS150. It's filed under PZX, implantable left atrial appendage clips, and the record doesn't say how the models differ.
Class II, 21 CFR 878.4300. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Edwards filed from Irvine, California. Review took 179 calendar days (December 29, 2025 to June 26, 2026).
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
- Product 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
Recent devices under product code PZX
view allMore clearances from Edwards Lifesciences
view allAdverse 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.