510(k) Report

Devices descending from K050954

65 later devices reach Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+1K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+1K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+1K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+1K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+1K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+1K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+1K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+1K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+2K192068i-ED COILKaneka Pharma America, LLC20201—
+2K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+2K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+2K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+2K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+2K123384Azur CX Detachable 18MicroVention, Inc.20123—
+2K120630Azur Detachable 18MicroVention, Inc.201243
+2K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+2K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+2K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+2K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+2K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+2K090357Hydroframe (Hes)MicroVention, Inc.2009142
+2K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+3K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+3K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+3K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+3K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+3K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+3K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+3K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+3K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+3K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+3K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K122316Azur Detachable 35MicroVention, Inc.20120—
+3K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+3K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+3K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+3K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+3K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+3K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+4K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+4K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+4K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+4K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+4K123338Barricade Embolization Coil SystemBlockade Medical201315—
+4K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+5K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+5K191680AZUR Vascular PlugMicroVention, Inc.20200—
+5K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+5K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+5K151760Barricade Embolization Coil SystemBlockade Medical201510—
+5K142513Barricade Embolization Coil SystemBlockade Medical201411—
+5K140104Barricade Embolization Coil SystemBlockade Medical201412—
+5K132482Barricade Embolization Coil SystemBlockade Medical201313—
+5K131475Barricade Embolization Coil SystemBlockade Medical201314—
+6K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+6K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+6K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+7K200030Optima Coil SystemBalt USA, LLC202065
+8K223386Optima Coil SystemBalt USA, LLC202231
+8K220699Prestige Coil SystemBait USA, LLC202212
+9K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+9K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+10K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+11K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—