510(k) Report

Devices descending from K925813

240 later devices reach Diagnostic Intravascular Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target2001812
+1K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target20006—
+1K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics1997150—
+2K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3Asahi Intecc Co., Ltd.20240—
+2K083343Headway 17 MicrocatheterMicroVention, Inc.200839—
+2K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation20084—
+2K070126Occlusion Balloon CatheterSentreheart, Inc.20080—
+2K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp2004257
+2K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.200320—
+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—
+3K210601Plato 17 MicrocatheterScientia Vascular, LLC202111
+3K172014Wedge MicrocatheterMicroVention, Inc.20183—
+3K173548Merit Pursue MicrocatheterMerit Medical Systems, Inc.201801
+3K122684Reverse Medical MicrocatheterReverse Medical Corporation20122—
+3K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+3K120917Headway Duo MicrocatheterMicroVention, Inc.201212—
+3K113778Excelsior XT-27 MicrocatheterStryker Neurovascular201283
+3K101542Headway 17 Advanced MicrocatheterMicroVention, Inc.201031
+3K100826Penumbra Catherer 025Penumbra, Inc.20102—
+3K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc.200919—
+3K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation20093—
+3K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation20067—
+3K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular200501
+3K042539GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilBoston Scientific Corp2004862
+3K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+3K033726PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular20041—
+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—
+4K254071p17 XR MicrocatheterWallaby Medical20260—
+4K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…Stryker Neurovascular20250—
+4K232542Wedge XL Delivery CatheterMicroVention, Inc.20240—
+4K230609NG Delivery CatheterBalt USA, LLC20231—
+4K223560Plato 17 MicrocatheterScientia Vascular, Inc.202301
+4K203842Bendit21 MicrocatheterBend IT Technologies, Ltd.20221—
+4K182487CerusEndo MicrocatheterCerus Endovascular, Inc.20190—
+4K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+4K183045Eclipse 2LBalt USA, LLC20190—
+4K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+4K152840Lantern Delivery MicrocatheterPenumbra, Inc.20151—
+4K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+4K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.201331
+4K131482Sofia Distal Access CatheterMicroVention, Inc.201311—
+4K130858Reverse Medical MicrocatheterReverse Medical Corporation20131—
+4K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20134—
+4K110813Headway 27 MicrocatheterMicroVention, Inc.20118—
+4K103355GDC 360 Deteachable CoilBoston Scientific Corp2011163
+4K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation20112—
+4K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp201058—
+4K092666Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250Boston Scientific Corp20090—
+4K080379Micrus Microcoil System, Deltapaq 10 Stretch ResistantMicrus Endovascular Corporation200810—
+4K070656Hydrocoil Embolic System (Hes)MicroVention, Inc.200736—
+4K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation20076—
+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
+4K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+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—
+5K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.20250—
+5K252569Carrier XL Delivery CatheterBalt USA, LLC20250—
+5K242033Access25™ Delivery MicrocatheterPenumbra, Inc.20240—
+5K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+5K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+5K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+5K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20170—
+5K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil…MicroVention, Inc.20172—
+5K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.20164—
+5K142692Occlusion Balloon CatheterEmbolx, Inc.20151—
+5K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+5K142449Headway 27 MicrocatheterMicroVention, Inc.20155—
+5K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+5K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+5K130577Azur Pushable 18 & 35 SystemMicroVention, Inc.20131—
+5K123338Barricade Embolization Coil SystemBlockade Medical201315—
+5K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+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—
+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—
+5K083646Micrus Microcoli System, Deltaplush, Models CPL, DPLMicrus Endovascular Corporation200911