510(k) Report

Devices descending from K901337

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033372Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple ModelsMicro Therapeutics, Inc.200429—
+1K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target2000691
+1K993455Flipper Detachable Embolization CoilCook, Inc.200041—
+1K992121Embolization Coil SystemCook, Inc.19994—
+1K983483Vascular Occlusion SystemCordis Neurovascular, Inc.199978—
+1K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc.199879—
+1K964367Ces Vascular Occlusion SystemCordis Neurovascular, Inc.199780—
+2K123560Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…Codman & Shurtleff, Inc.20130—
+2K123712Retracta Detachable Embolization CoilCook Incorporated20133—
+2K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+2K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc.200732—
+2K063619Flipper Detachable Embolization CoilsCook, Inc.20061—
+2K041649Sapphire NXT Detachable Coil SystemMicro Therapeutics, Inc.200428—
+2K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+2K031810Amplatzer Vascular PlugAga Medical Corp.2003381
+2K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+3K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+3K160219Hilal Embolization MicroCoilsCook Incorporated201601
+3K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated201602
+3K150964MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated20150—
+3K151676Retracta Detachable Embolization CoilCook Incorporated20152—
+3K123696Medusa Vascular PlugEndoshape, Inc.20131—
+3K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+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
+3K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+3K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+3K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+3K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp.200716—
+3K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+3K060747FX Detachable Coil SystemMicro Therapeutics, Inc.2007232
+3K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+3K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc.200527—
+3K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation200520—
+3K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+4K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+4K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+4K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+4K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+4K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+4K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+4K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+4K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+4K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+4K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+4K140796Medusa Vascular Plug,Endoshape, Inc.20140—
+4K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+4K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+4K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+4K122316Azur Detachable 35MicroVention, Inc.20120—
+4K113658Amplatzer Vascular Plug 4Aga Medical Corp.201213—
+4K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+4K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+4K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+4K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+4K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+4K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+4K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+4K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+4K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+4K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+4K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.200715—
+4K060625Nexus Detachable Coil System, Morpheus 3D CSRMicro Therapeutics, Inc.20060—
+4K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc.200524—
+4K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc.200524—
+5K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+5K211563Pitch-PatchsXiros, Ltd.20212—
+5K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+5K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+5K192068i-ED COILKaneka Pharma America, LLC20201—
+5K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.20200—
+5K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+5K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+5K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+5K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+5K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+5K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+5K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+5K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+5K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+5K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+5K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+5K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+5K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+5K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+5K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+5K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+5K090357Hydroframe (Hes)MicroVention, Inc.2009142
+5K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+5K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+6K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+6K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+6K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+6K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+6K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+6K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+6K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+6K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+6K191680AZUR Vascular PlugMicroVention, Inc.20200—