510(k) Report

Devices descending from K181474

7 later devices reach ArtiClip LAA Exclusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+2K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+3K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+3K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+3K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+4K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+4K232295LAA Exclusion SystemSyntheon, LLC20231—