510(k) Report

Devices descending from K001083

143 later devices reach Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+1K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp2004862
+1K031049Guglielmi Detachable Coil (GDC)Boston Scientific, Target200360—
+1K030475GDC Stretch Resistant Detachable CoilBoston Scientific, Target20031281
+1K021494GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target200260—
+1K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+1K012985Matrix Detachable CoilsBoston Scientific, Target200212210
+2K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+2K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+2K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+2K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+2K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+2K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+2K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+2K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+2K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+2K050543Nexus Detachable Coil SystemMicro Therapeutics, Inc.200527—
+2K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+2K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target200310010
+2K020434Microplex Coil System (MCS)MicroVention, Inc.200270—
+3K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+3K191680AZUR Vascular PlugMicroVention, Inc.20200—
+3K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+3K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+3K143218Penumbra Smart CoilPenumbra, Inc.20154—
+3K141134Pod SystemPenumbra, Inc.20141—
+3K123338Barricade Embolization Coil SystemBlockade Medical201315—
+3K120850Target Detachable CoilStryker Neurovascular201201
+3K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+3K113412Target Detachable CoilStryker Neurovascular20111328
+3K112385Traget Detachable CoilStryker Neurovascular201115—
+3K103008Inzone Detachment SystemBoston Scientific Corp201021—
+3K102672Target Detachable CoilBoston Scientific Corp201016—
+3K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+3K060747FX Detachable Coil SystemMicro Therapeutics, Inc.2007232
+3K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+3K060625Nexus Detachable Coil System, Morpheus 3D CSRMicro Therapeutics, Inc.20060—
+3K051560Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSRMicro Therapeutics, Inc.200524—
+3K051425Nexus Detachable Coil System, Helix Super Soft CSRMicro Therapeutics, Inc.200524—
+3K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+3K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.200368—
+3K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc.20020—
+4K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+4K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+4K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+4K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+4K170852POD Packing CoilPenumbra, Inc.20170—
+4K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+4K160832Penumbra Smart CoilPenumbra, Inc.20162—
+4K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+4K151760Barricade Embolization Coil SystemBlockade Medical201510—
+4K151572Penumbra Smart CoilPenumbra, Inc.20153—
+4K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+4K142513Barricade Embolization Coil SystemBlockade Medical201411—
+4K140104Barricade Embolization Coil SystemBlockade Medical201412—
+4K132482Barricade Embolization Coil SystemBlockade Medical201313—
+4K131475Barricade Embolization Coil SystemBlockade Medical201314—
+4K123377Target Detachable CoilStryker Neurovascular201212—
+4K120816Inzone Detachment SystemStryker20129—
+4K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+4K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+4K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+4K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+4K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+4K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+4K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+4K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+5K250079Ruby XL SystemPenumbra, Inc.20250—
+5K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+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—
+5K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+5K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+5K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+5K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+5K153658Target Detachable CoilsStryker Neurovascular20161128
+5K160096InZone Detachment SystemStryker Neurovascular20168—
+5K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+5K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+5K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+5K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+5K123384Azur CX Detachable 18MicroVention, Inc.20123—
+5K120630Azur Detachable 18MicroVention, Inc.201243
+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
+5K090168Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415MicroVention, Inc.200918—
+5K090001V-Grip Plus Detachment Controller, Model VG503MicroVention, Inc.20090—
+5K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+5K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+6K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+6K242243Target Detachable CoilsStryker Neurovscular20242—
+6K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+6K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+6K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+6K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+6K212455InZone Detachment SystemStryker Neurovascular202111
+6K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+6K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—