510(k) Report

Devices descending from K093358

22 later devices reach Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+1K123338Barricade Embolization Coil SystemBlockade Medical201315—
+1K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+1K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+2K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+2K151760Barricade Embolization Coil SystemBlockade Medical201510—
+2K142513Barricade Embolization Coil SystemBlockade Medical201411—
+2K140104Barricade Embolization Coil SystemBlockade Medical201412—
+2K132482Barricade Embolization Coil SystemBlockade Medical201313—
+2K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+2K131475Barricade Embolization Coil SystemBlockade Medical201314—
+3K192068i-ED COILKaneka Pharma America, LLC20201—
+3K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+3K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+4K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+4K200030Optima Coil SystemBalt USA, LLC202065
+5K223386Optima Coil SystemBalt USA, LLC202231
+5K220699Prestige Coil SystemBait USA, LLC202212
+6K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+6K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+7K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+8K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—