510(k) Report

Devices descending from K925813

240 later devices reach Diagnostic Intravascular Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+8K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+8K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+8K250079Ruby XL SystemPenumbra, Inc.20250—
+8K242243Target Detachable CoilsStryker Neurovscular20242—
+8K240384SENDERO MicrocatheterOkami Medical, Inc.20241—
+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—
+8K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+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—
+9K242644SENDERO MAX Delivery CatheterOkami Medical, Inc.20240—
+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—