510(k) Report

Devices descending from K912293

151 later devices reach Remove Labeling Restrict From Guide Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+7K151572Penumbra Smart CoilPenumbra, Inc.20153—
+7K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+7K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+7K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+7K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+7K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+7K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+7K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+7K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+7K122316Azur Detachable 35MicroVention, Inc.20120—
+7K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+7K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+7K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+7K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+7K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+8K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+8K250079Ruby XL SystemPenumbra, Inc.20250—
+8K242243Target Detachable CoilsStryker Neurovscular20242—
+8K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+8K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+8K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+8K212455InZone Detachment SystemStryker Neurovascular202111
+8K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+8K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+8K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+8K191680AZUR Vascular PlugMicroVention, Inc.20200—
+8K200030Optima Coil SystemBalt USA, LLC202065
+8K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+8K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+8K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+8K161429Target Detachable CoilsStryker Neurovascular201610—
+8K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+8K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+9K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+9K252694Target Detachable CoilStryker Neurovascular20251—
+9K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+9K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+9K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+9K223386Optima Coil SystemBalt USA, LLC202231
+9K220699Prestige Coil SystemBait USA, LLC202212
+9K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+9K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+10K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+10K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+10K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+10K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+10K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+11K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+11K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+12K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—