510(k) Report

Devices descending from K961810

409 later devices reach Supple Peri-Guard Pericardium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K180010AtriClip FLEX-VAtriCure, Inc.20188—
+11K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+12K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+13K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+14K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+14K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+14K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+15K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+15K232295LAA Exclusion SystemSyntheon, LLC20231—