510(k) Report

Devices descending from K103008

21 later devices reach Inzone Detachment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+1K120816Inzone Detachment SystemStryker20129—
+2K160096InZone Detachment SystemStryker Neurovascular20168—
+2K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+2K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+2K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+2K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+3K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+3K212455InZone Detachment SystemStryker Neurovascular202111
+3K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+3K192068i-ED COILKaneka Pharma America, LLC20201—
+3K191680AZUR Vascular PlugMicroVention, Inc.20200—
+3K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+3K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+4K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+4K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+4K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+4K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+4K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+5K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+6K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—