510(k) Report

Devices descending from K971395

150 later devices reach Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+1K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target200098—
+1K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target2000691
+1K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target2000105—
+1K991139Guglielmi Detachable (GDC)Boston Scientific, Target1999138—
+2K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp2004862
+2K033836Hydrocoil Embolic System (Hes)MicroVention, Inc.200367—
+2K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp.2002103—
+2K020434Microplex Coil System (MCS)MicroVention, Inc.200270—
+2K021494GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target200260—
+2K012145Microplex Coil SystemMicroVention, Inc.200196—
+3K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+3K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+3K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+3K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation200810—
+3K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+3K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+3K062036Micrus Microcoil System Presidio-18, Model PC4Micrus Endovascular Corporation2006341
+3K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc.20056516
+3K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+3K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc.200466—
+3K033813Micrus Modified Microcoil System, CerecyteMicrus Corp.200440—
+3K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.200368—
+3K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp.200391—
+3K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc.20020—
+3K021914Microplex Coil Systems (MCS)MicroVention, Inc.20021—
+4K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+4K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+4K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+4K123338Barricade Embolization Coil SystemBlockade Medical201315—
+4K120850Target Detachable CoilStryker Neurovascular201201
+4K120274Deltamaxx 18 Microcoil SystemCodman and Shurtleff, Inc.20121—
+4K113412Target Detachable CoilStryker Neurovascular20111328
+4K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+4K112385Traget Detachable CoilStryker Neurovascular201115—
+4K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+4K103008Inzone Detachment SystemBoston Scientific Corp201021—
+4K102672Target Detachable CoilBoston Scientific Corp201016—
+4K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+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—
+4K083646Micrus Microcoli System, Deltaplush, Models CPL, DPLMicrus Endovascular Corporation200911
+4K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+4K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+4K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+4K080437Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation200810—
+4K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+4K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+4K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+4K071246Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…Micrus Endovascular Corporation20070—
+4K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+4K053160Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation200535—
+5K192068i-ED COILKaneka Pharma America, LLC20201—
+5K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+5K151760Barricade Embolization Coil SystemBlockade Medical201510—
+5K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+5K143218Penumbra Smart CoilPenumbra, Inc.20154—
+5K142513Barricade Embolization Coil SystemBlockade Medical201411—
+5K141134Pod SystemPenumbra, Inc.20141—
+5K140104Barricade Embolization Coil SystemBlockade Medical201412—
+5K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+5K132482Barricade Embolization Coil SystemBlockade Medical201313—
+5K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+5K131475Barricade Embolization Coil SystemBlockade Medical201314—
+5K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+5K123377Target Detachable CoilStryker Neurovascular201212—
+5K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+5K123384Azur CX Detachable 18MicroVention, Inc.20123—
+5K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+5K120816Inzone Detachment SystemStryker20129—
+5K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+5K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+5K120630Azur Detachable 18MicroVention, Inc.201243
+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
+5K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+5K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+5K090357Hydroframe (Hes)MicroVention, Inc.2009142
+5K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+6K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+6K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+6K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+6K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+6K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+6K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+6K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+6K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+6K170852POD Packing CoilPenumbra, Inc.20170—
+6K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+6K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+6K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+6K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+6K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+6K153658Target Detachable CoilsStryker Neurovascular20161128
+6K160832Penumbra Smart CoilPenumbra, Inc.20162—
+6K160096InZone Detachment SystemStryker Neurovascular20168—
+6K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+6K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—