510(k) Report

Devices descending from K960705

190 later devices reach Guglielmi Detachable Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031810Amplatzer Vascular PlugAga Medical Corp.2003381
+1K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+1K993455Flipper Detachable Embolization CoilCook, Inc.200041—
+1K992121Embolization Coil SystemCook, Inc.19994—
+1K964488Detachable Silicone Balloon (DSB)Target Therapeutics19980—
+1K965071Detachable Slicone Balloon (DSB)Target Therapeutics19980—
+1K962503Guglielmi Detachable CoilTarget Therapeutics1996182—
+2K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+2K123696Medusa Vascular PlugEndoshape, Inc.20131—
+2K123712Retracta Detachable Embolization CoilCook Incorporated20133—
+2K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+2K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+2K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp.200716—
+2K063619Flipper Detachable Embolization CoilsCook, Inc.20061—
+2K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation200520—
+2K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target200098—
+2K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target2000691
+2K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target2000105—
+2K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999138—
+2K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150—
+3K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+3K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+3K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+3K160219Hilal Embolization MicroCoilsCook Incorporated201601
+3K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated201602
+3K150964MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated20150—
+3K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+3K151676Retracta Detachable Embolization CoilCook Incorporated20152—
+3K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+3K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+3K140796Medusa Vascular Plug,Endoshape, Inc.20140—
+3K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+3K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K113658Amplatzer Vascular Plug 4Aga Medical Corp.201213—
+3K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+3K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation200817—
+3K071699Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022Aga Medical Corp.200715—
+3K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp2004862
+3K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+3K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002103—
+3K020434Microplex Coil System (MCS)MicroVention, Inc.200270—
+3K021494GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target200260—
+3K012145Microplex Coil SystemMicroVention, Inc.200196—
+4K243480SuturePatch Tissue ReinforcementArthrex, Inc.20250—
+4K211563Pitch-PatchsXiros, Ltd.20212—
+4K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+4K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+4K191532The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc.20200—
+4K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+4K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+4K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+4K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+4K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+4K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+4K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+4K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+4K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+4K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+4K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+4K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation20093—
+4K072370Surgicraft Surgical Mesh SystemSurgicraft, Ltd.200811—
+4K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation200810—
+4K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+4K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+4K062036Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation2006341
+4K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+4K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+4K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+4K033813Micrus Modified Microcoil System, CerecyteMicrus Corp.200440—
+4K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.200368—
+4K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp.200391—
+4K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc.20020—
+4K021914Microplex Coil Systems (MCS)MicroVention, Inc.20021—
+5K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+5K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…ZuriMED Technologies AG20241—
+5K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+5K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+5K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+5K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+5K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+5K191680AZUR Vascular PlugMicroVention, Inc.20200—
+5K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+5K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+5K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+5K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+5K123338Barricade Embolization Coil SystemBlockade Medical201315—
+5K120850Target Detachable CoilStryker Neurovascular201201
+5K120274Deltamaxx 18 Microcoil SystemCodman and Shurtleff, Inc.20121—
+5K112499Biomerix Composite Surgical MeshBiomerix Corporation20110—
+5K113412Target Detachable CoilStryker Neurovascular20111328
+5K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+5K112385Traget Detachable CoilStryker Neurovascular201115—
+5K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+5K103008Inzone Detachment SystemBoston Scientific Corp201021—
+5K102672Target Detachable CoilBoston Scientific Corp201016—
+5K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation20101—
+5K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+5K091641Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)MicroVention, Inc.2009236
+5K090288Orthadapt PRPegasus Biologics, Inc.20097—