510(k) Report

Devices descending from K153500

10 later devices reach AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+2K180010AtriClip FLEX-VAtriCure, Inc.20188—
+3K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+4K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+5K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+6K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+6K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+6K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+7K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+7K232295LAA Exclusion SystemSyntheon, LLC20231—