510(k) Report

Devices descending from K891688

189 later devices reach Coil and Coil Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040342Interlocking Detachable Coil System (Idc)Boston Scientific Corp20041—
+1K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150—
+1K964367Ces Vascular Occlusion SystemCordis Neurovascular, Inc.199780—
+2K141378Idc Interlocking Detachable CoilBoston Scientific Corporation20140—
+2K123560Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…Codman & Shurtleff, Inc.20130—
+2K014041Trufill DCS Detachable Coil and Frufill DCS Syringe, Also Known as the Trufill DCS…Cordis Neurovascular20020—
+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—
+2K983483Vascular Occlusion SystemCordis Neurovascular, Inc.199978—
+2K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc.199879—
+3K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+3K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc.200732—
+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—
+3K993455Flipper Detachable Embolization CoilCook, Inc.200041—
+4K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+4K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+4K123384Azur CX Detachable 18MicroVention, Inc.20123—
+4K120630Azur Detachable 18MicroVention, Inc.201243
+4K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+4K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+4K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+4K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+4K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc.20095—
+4K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation200810—
+4K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+4K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+4K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+4K063619Flipper Detachable Embolization CoilsCook, Inc.20061—
+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—
+4K031810Amplatzer Vascular PlugAga Medical Corp.2003381
+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—
+5K250133HARBOR Occlusion DeviceNuvascular, Inc.20251—
+5K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+5K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+5K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+5K150964MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated20150—
+5K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+5K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+5K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+5K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+5K123696Medusa Vascular PlugEndoshape, Inc.20131—
+5K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+5K123338Barricade Embolization Coil SystemBlockade Medical201315—
+5K122316Azur Detachable 35MicroVention, Inc.20120—
+5K120850Target Detachable CoilStryker Neurovascular201201
+5K120274Deltamaxx 18 Microcoil SystemCodman and Shurtleff, Inc.20121—
+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—
+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—
+5K083646Micrus Microcoli System, Deltaplush, Models CPL, DPLMicrus Endovascular Corporation200911
+5K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+5K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+5K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+5K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+5K080437Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation200810—
+5K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+5K071125Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012…Aga Medical Corp.200716—
+5K071246Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…Micrus Endovascular Corporation20070—
+5K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+5K053160Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation200535—
+5K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation200520—
+6K260635HARBOR Occlusion DeviceNuvascular, Inc.20260—
+6K192068i-ED COILKaneka Pharma America, LLC20201—
+6K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+6K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+6K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+6K151760Barricade Embolization Coil SystemBlockade Medical201510—
+6K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+6K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+6K143218Penumbra Smart CoilPenumbra, Inc.20154—
+6K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+6K140796Medusa Vascular Plug,Endoshape, Inc.20140—
+6K142513Barricade Embolization Coil SystemBlockade Medical201411—
+6K141134Pod SystemPenumbra, Inc.20141—
+6K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+6K140104Barricade Embolization Coil SystemBlockade Medical201412—
+6K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+6K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+6K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+6K132482Barricade Embolization Coil SystemBlockade Medical201313—