510(k) Report

Devices descending from K031168

100 later devices reach Matrix Stretch Resistant Detachable Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+1K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+2K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+2K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+3K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+3K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+3K123338Barricade Embolization Coil SystemBlockade Medical201315—
+3K120850Target Detachable CoilStryker Neurovascular201201
+3K113412Target Detachable CoilStryker Neurovascular20111328
+3K112385Traget Detachable CoilStryker Neurovascular201115—
+3K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+3K103008Inzone Detachment SystemBoston Scientific Corp201021—
+3K102672Target Detachable CoilBoston Scientific Corp201016—
+3K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+3K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+3K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+3K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+3K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+3K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+3K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+4K192068i-ED COILKaneka Pharma America, LLC20201—
+4K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+4K151760Barricade Embolization Coil SystemBlockade Medical201510—
+4K143218Penumbra Smart CoilPenumbra, Inc.20154—
+4K142513Barricade Embolization Coil SystemBlockade Medical201411—
+4K141134Pod SystemPenumbra, Inc.20141—
+4K140104Barricade Embolization Coil SystemBlockade Medical201412—
+4K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+4K132482Barricade Embolization Coil SystemBlockade Medical201313—
+4K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+4K131475Barricade Embolization Coil SystemBlockade Medical201314—
+4K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+4K123377Target Detachable CoilStryker Neurovascular201212—
+4K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+4K123384Azur CX Detachable 18MicroVention, Inc.20123—
+4K120816Inzone Detachment SystemStryker20129—
+4K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+4K120630Azur Detachable 18MicroVention, Inc.201243
+4K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+4K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+4K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+4K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+4K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+4K090357Hydroframe (Hes)MicroVention, Inc.2009142
+4K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+5K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+5K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+5K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+5K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+5K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+5K170852POD Packing CoilPenumbra, Inc.20170—
+5K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+5K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+5K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+5K153658Target Detachable CoilsStryker Neurovascular20161128
+5K160832Penumbra Smart CoilPenumbra, Inc.20162—
+5K160096InZone Detachment SystemStryker Neurovascular20168—
+5K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+5K151572Penumbra Smart CoilPenumbra, Inc.20153—
+5K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+5K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+5K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+5K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+5K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+5K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+5K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+5K122316Azur Detachable 35MicroVention, Inc.20120—
+5K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+5K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+5K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+5K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+5K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+5K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+6K250079Ruby XL SystemPenumbra, Inc.20250—
+6K242243Target Detachable CoilsStryker Neurovscular20242—
+6K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+6K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+6K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+6K212455InZone Detachment SystemStryker Neurovascular202111
+6K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+6K191680AZUR Vascular PlugMicroVention, Inc.20200—
+6K200030Optima Coil SystemBalt USA, LLC202065
+6K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+6K161429Target Detachable CoilsStryker Neurovascular201610—
+6K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+6K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+7K252694Target Detachable CoilStryker Neurovascular20251—
+7K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+7K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+7K223386Optima Coil SystemBalt USA, LLC202231
+7K220699Prestige Coil SystemBait USA, LLC202212
+7K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+7K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+8K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+8K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+8K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+8K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+9K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+9K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+10K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—