510(k) Report

Devices descending from K012985

122 later devices reach Matrix Detachable Coils through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+6K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+6K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+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—
+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—
+7K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+7K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+8K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+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—
+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—