510(k) Report

Devices descending from K001083

143 later devices reach Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+6K200030Optima Coil SystemBalt USA, LLC202065
+6K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+6K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+6K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+6K161429Target Detachable CoilsStryker Neurovascular201610—
+6K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+6K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+6K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+6K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+6K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+6K122316Azur Detachable 35MicroVention, Inc.20120—
+6K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+6K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+6K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+6K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+6K090357Hydroframe (Hes)MicroVention, Inc.2009142
+6K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+7K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+7K261866Concerto Versa™ Detachable CoilMedtronic, 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
+7K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+7K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+7K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+7K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+7K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+7K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+7K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+7K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+7K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+7K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+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—
+8K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+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—