510(k) Report

Devices descending from K901337

139 later devices reach Hilal Embolization Microcoil (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+6K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+6K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+6K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+6K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+6K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+6K123338Barricade Embolization Coil SystemBlockade Medical201315—
+6K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+6K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+6K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+6K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+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—
+6K090288Orthadapt PRPegasus Biologics, Inc.20097—
+7K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+7K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+7K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG20260—
+7K151760Barricade Embolization Coil SystemBlockade Medical201510—
+7K142513Barricade Embolization Coil SystemBlockade Medical201411—
+7K140104Barricade Embolization Coil SystemBlockade Medical201412—
+7K132482Barricade Embolization Coil SystemBlockade Medical201313—
+7K131475Barricade Embolization Coil SystemBlockade Medical201314—
+7K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+7K112567Biomerix AssureBiomerix Corporation20110—
+7K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+7K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+8K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+8K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+9K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+9K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+9K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+9K200030Optima Coil SystemBalt USA, LLC202065
+10K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+10K223386Optima Coil SystemBalt USA, LLC202231
+10K220699Prestige Coil SystemBait USA, LLC202212
+11K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+11K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+12K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+13K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—