510(k) Report

Devices descending from K951256

192 later devices reach Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+5K103008Inzone Detachment SystemBoston Scientific Corp201021—
+5K102672Target Detachable CoilBoston Scientific Corp201016—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+5K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+5K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+5K090288Orthadapt PRPegasus Biologics, Inc.20097—
+5K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+5K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+5K083646Micrus Microcoli System, Deltaplush, Models CPL, DPLMicrus Endovascular Corporation200911
+5K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+5K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+5K080437Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation200810—
+5K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+5K071246Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…Micrus Endovascular Corporation20070—
+5K053160Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation200535—
+6K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+6K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+6K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+6K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+6K192068i-ED COILKaneka Pharma America, LLC20201—
+6K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+6K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+6K151760Barricade Embolization Coil SystemBlockade Medical201510—
+6K143218Penumbra Smart CoilPenumbra, Inc.20154—
+6K142513Barricade Embolization Coil SystemBlockade Medical201411—
+6K141134Pod SystemPenumbra, Inc.20141—
+6K140104Barricade Embolization Coil SystemBlockade Medical201412—
+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—
+6K132482Barricade Embolization Coil SystemBlockade Medical201313—
+6K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+6K131475Barricade Embolization Coil SystemBlockade Medical201314—
+6K123377Target Detachable CoilStryker Neurovascular201212—
+6K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+6K122316Azur Detachable 35MicroVention, Inc.20120—
+6K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+6K120816Inzone Detachment SystemStryker20129—
+6K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+6K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+6K112567Biomerix AssureBiomerix Corporation20110—
+6K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+6K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+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
+7K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+7K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+7K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+7K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+7K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+7K170852POD Packing CoilPenumbra, Inc.20170—
+7K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+7K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+7K153658Target Detachable CoilsStryker Neurovascular20161128
+7K160832Penumbra Smart CoilPenumbra, Inc.20162—
+7K160096InZone Detachment SystemStryker Neurovascular20168—
+7K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+7K151572Penumbra Smart CoilPenumbra, Inc.20153—
+7K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+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—
+8K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+8K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+8K250079Ruby XL SystemPenumbra, Inc.20250—
+8K242243Target Detachable CoilsStryker Neurovscular20242—
+8K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+8K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+8K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+8K212455InZone Detachment SystemStryker Neurovascular202111
+8K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+8K200030Optima Coil SystemBalt USA, LLC202065
+8K161429Target Detachable CoilsStryker Neurovascular201610—
+8K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+9K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+9K252694Target Detachable CoilStryker Neurovascular20251—
+9K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+9K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+9K223386Optima Coil SystemBalt USA, LLC202231
+9K220699Prestige Coil SystemBait USA, LLC202212
+10K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+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—