510(k) Report

Devices descending from K971395

150 later devices reach Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151572Penumbra Smart CoilPenumbra, Inc.20153—
+6K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+6K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+6K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+6K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+6K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+6K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+6K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+6K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+6K122316Azur Detachable 35MicroVention, Inc.20120—
+6K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+6K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+6K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+6K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+6K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+7K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+7K250079Ruby XL SystemPenumbra, Inc.20250—
+7K242243Target Detachable CoilsStryker Neurovscular20242—
+7K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+7K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+7K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+7K212455InZone Detachment SystemStryker Neurovascular202111
+7K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+7K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+7K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+7K191680AZUR Vascular PlugMicroVention, Inc.20200—
+7K200030Optima Coil SystemBalt USA, LLC202065
+7K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+7K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+7K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+7K161429Target Detachable CoilsStryker Neurovascular201610—
+7K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+7K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+8K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+8K252694Target Detachable CoilStryker Neurovascular20251—
+8K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+8K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+8K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+8K223386Optima Coil SystemBalt USA, LLC202231
+8K220699Prestige Coil SystemBait USA, LLC202212
+8K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+8K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+9K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+9K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+9K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+9K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+9K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+10K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+10K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+11K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—