510(k) Report

Devices descending from K031623

32 later devices reach Modification to Coalescent Surgical U-Clip and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+1K062057U-Clip Device, Model NC65Medtronic Vascular20062—
+1K053252U-Clip Device, Models B140, B160 and B180Medtronic Vascular20051—
+1K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc.20057—
+1K040821Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical20040—
+2K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+2K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+2K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+2K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+2K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+2K081082U-Clip Uni-Fire, Model M65Medtronic, Inc.20080—
+2K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200751
+2K062821U-Clip DeviceMedtronic Neurosurgery20060—
+2K053524C-Port Distal Anastomosis SystemCardica, Inc.200661
+3K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+3K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+3K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+3K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200911
+3K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change SubassembliesCardica, Inc.20070—
+3K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.200711
+4K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+4K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.201001
+4K073123Cardica C-Port Flex-a Distal Anastomosis System, Model FG-000150Cardica, Inc.200701
+5K180010AtriClip FLEX-VAtriCure, Inc.20188—
+6K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+7K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+8K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+9K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+9K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+9K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+10K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+10K232295LAA Exclusion SystemSyntheon, LLC20231—