510(k) Report

Devices descending from K021494

60 later devices reach GDC Power Supply, Model GDC Power Supply: 451007-4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+1K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+2K123338Barricade Embolization Coil SystemBlockade Medical201315—
+2K120850Target Detachable CoilStryker Neurovascular201201
+2K113412Target Detachable CoilStryker Neurovascular20111328
+2K112385Traget Detachable CoilStryker Neurovascular201115—
+2K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+2K103008Inzone Detachment SystemBoston Scientific Corp201021—
+2K102672Target Detachable CoilBoston Scientific Corp201016—
+3K151760Barricade Embolization Coil SystemBlockade Medical201510—
+3K143218Penumbra Smart CoilPenumbra, Inc.20154—
+3K142513Barricade Embolization Coil SystemBlockade Medical201411—
+3K141134Pod SystemPenumbra, Inc.20141—
+3K140104Barricade Embolization Coil SystemBlockade Medical201412—
+3K132482Barricade Embolization Coil SystemBlockade Medical201313—
+3K131475Barricade Embolization Coil SystemBlockade Medical201314—
+3K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K123377Target Detachable CoilStryker Neurovascular201212—
+3K120816Inzone Detachment SystemStryker20129—
+3K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+4K192068i-ED COILKaneka Pharma America, LLC20201—
+4K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+4K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+4K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+4K170852POD Packing CoilPenumbra, Inc.20170—
+4K153658Target Detachable CoilsStryker Neurovascular20161128
+4K160832Penumbra Smart CoilPenumbra, Inc.20162—
+4K160096InZone Detachment SystemStryker Neurovascular20168—
+4K151572Penumbra Smart CoilPenumbra, Inc.20153—
+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—
+5K250079Ruby XL SystemPenumbra, Inc.20250—
+5K242243Target Detachable CoilsStryker Neurovscular20242—
+5K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+5K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+5K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+5K212455InZone Detachment SystemStryker Neurovascular202111
+5K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+5K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+5K191680AZUR Vascular PlugMicroVention, Inc.20200—
+5K200030Optima Coil SystemBalt USA, LLC202065
+5K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+5K161429Target Detachable CoilsStryker Neurovascular201610—
+5K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+6K252694Target Detachable CoilStryker Neurovascular20251—
+6K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+6K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+6K223386Optima Coil SystemBalt USA, LLC202231
+6K220699Prestige Coil SystemBait USA, LLC202212
+6K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+6K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+7K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+7K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+7K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+7K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+8K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+8K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+9K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—