510(k) Report

Devices descending from K042539

86 later devices reach GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+1K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+1K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+1K050700Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp2005591
+2K123338Barricade Embolization Coil SystemBlockade Medical201315—
+2K120850Target Detachable CoilStryker Neurovascular201201
+2K113412Target Detachable CoilStryker Neurovascular20111328
+2K112385Traget Detachable CoilStryker Neurovascular201115—
+2K103305Penumbra Embolization Coil SystemPenumbra, Inc.2011101
+2K103008Inzone Detachment SystemBoston Scientific Corp201021—
+2K102672Target Detachable CoilBoston Scientific Corp201016—
+2K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+2K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+3K151760Barricade Embolization Coil SystemBlockade Medical201510—
+3K143218Penumbra Smart CoilPenumbra, Inc.20154—
+3K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+3K142513Barricade Embolization Coil SystemBlockade Medical201411—
+3K141134Pod SystemPenumbra, Inc.20141—
+3K140104Barricade Embolization Coil SystemBlockade Medical201412—
+3K132482Barricade Embolization Coil SystemBlockade Medical201313—
+3K131475Barricade Embolization Coil SystemBlockade Medical201314—
+3K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+3K123377Target Detachable CoilStryker Neurovascular201212—
+3K120816Inzone Detachment SystemStryker20129—
+3K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+3K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+3K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+3K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+4K192068i-ED COILKaneka Pharma America, LLC20201—
+4K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+4K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+4K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+4K170852POD Packing CoilPenumbra, Inc.20170—
+4K153658Target Detachable CoilsStryker Neurovascular20161128
+4K160832Penumbra Smart CoilPenumbra, Inc.20162—
+4K160096InZone Detachment SystemStryker Neurovascular20168—
+4K151572Penumbra Smart CoilPenumbra, Inc.20153—
+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—
+4K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+4K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+4K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+4K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+5K250079Ruby XL SystemPenumbra, Inc.20250—
+5K242243Target Detachable CoilsStryker Neurovscular20242—
+5K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+5K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+5K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+5K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+5K212455InZone Detachment SystemStryker Neurovascular202111
+5K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+5K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+5K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+5K191680AZUR Vascular PlugMicroVention, Inc.20200—
+5K200030Optima Coil SystemBalt USA, LLC202065
+5K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+5K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+5K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+5K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+5K161429Target Detachable CoilsStryker Neurovascular201610—
+5K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+5K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+5K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+5K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+6K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+6K252694Target Detachable CoilStryker Neurovascular20251—
+6K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+6K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+6K223386Optima Coil SystemBalt USA, LLC202231
+6K220699Prestige Coil SystemBait USA, LLC202212
+6K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+6K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+6K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+6K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+6K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+6K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+7K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+7K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+7K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+7K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+7K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+7K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+8K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+8K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+8K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+9K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—