510(k) 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) by Edwards Lifesciences — Product Code PZX

K254232 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "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)". The FDA issued a decision of Substantially Equivalent on June 26, 2026. The device falls under product code PZX (Left Atrial Appendage Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Edwards Lifesciences has at least 10 other 510(k) clearances on record.