510(k) Report

Devices descending from K031578

91 later devices reach Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+1K071246Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…Micrus Endovascular Corporation20070—
+1K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+1K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.200368—
+2K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+2K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+2K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+2K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+2K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+2K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+2K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+2K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+2K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+2K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+2K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+2K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+2K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+2K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+3K192068i-ED COILKaneka Pharma America, LLC20201—
+3K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+3K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+3K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+3K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+3K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+3K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+3K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+3K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+3K123384Azur CX Detachable 18MicroVention, Inc.20123—
+3K120630Azur Detachable 18MicroVention, Inc.201243
+3K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+3K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+3K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+3K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+3K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+3K090357Hydroframe (Hes)MicroVention, Inc.2009142
+3K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+3K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+4K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+4K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+4K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+4K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+4K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+4K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+4K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+4K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+4K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+4K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+4K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+4K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+4K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+4K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+4K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+4K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+4K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+4K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+4K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+4K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+4K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+4K122316Azur Detachable 35MicroVention, Inc.20120—
+4K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+4K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+4K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+4K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+4K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+4K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+5K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+5K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+5K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+5K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+5K191680AZUR Vascular PlugMicroVention, Inc.20200—
+5K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+5K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+5K123338Barricade Embolization Coil SystemBlockade Medical201315—
+5K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+6K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+6K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+6K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+6K151760Barricade Embolization Coil SystemBlockade Medical201510—
+6K142513Barricade Embolization Coil SystemBlockade Medical201411—
+6K140104Barricade Embolization Coil SystemBlockade Medical201412—
+6K132482Barricade Embolization Coil SystemBlockade Medical201313—
+6K131475Barricade Embolization Coil SystemBlockade Medical201314—
+7K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+8K200030Optima Coil SystemBalt USA, LLC202065
+9K223386Optima Coil SystemBalt USA, LLC202231
+9K220699Prestige Coil SystemBait USA, LLC202212
+10K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+10K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+11K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+12K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—