510(k) Report

Devices descending from K891688

189 later devices reach Coil and Coil Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+6K131475Barricade Embolization Coil SystemBlockade Medical201314—
+6K123377Target Detachable CoilStryker Neurovascular201212—
+6K113658Amplatzer Vascular Plug 4Aga Medical Corp.201213—
+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—
+6K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+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
+6K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+6K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+6K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.200715—
+7K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+7K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+7K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+7K211563Pitch-PatchsXiros, Ltd.20212—
+7K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+7K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+7K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+7K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+7K191680AZUR Vascular PlugMicroVention, Inc.20200—
+7K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.20200—
+7K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+7K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+7K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+7K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+7K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+7K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+7K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+7K170852POD Packing CoilPenumbra, Inc.20170—
+7K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+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
+7K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+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—
+7K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+7K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+8K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+8K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+8K250079Ruby XL SystemPenumbra, Inc.20250—
+8K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+8K242243Target Detachable CoilsStryker Neurovscular20242—
+8K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+8K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+8K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+8K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+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—
+8K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+8K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+8K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+8K090288Orthadapt PRPegasus Biologics, Inc.20097—
+9K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+9K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+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
+9K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+9K112567Biomerix AssureBiomerix Corporation20110—
+9K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+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—
+10K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+11K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+11K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+11K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+11K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+11K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+12K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+12K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—