510(k) Report

Devices descending from K030475

128 later devices reach GDC Stretch Resistant Detachable Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+7K252694Target Detachable CoilStryker Neurovascular20251—
+7K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+7K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+7K223386Optima Coil SystemBalt USA, LLC202231
+7K220699Prestige Coil SystemBait USA, LLC202212
+7K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+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—
+7K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+7K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+7K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+7K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+8K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+8K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+8K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+8K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+8K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+8K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+9K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+9K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+9K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+10K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—