510(k) Report

Devices descending from K010954

187 later devices reach Concentric Balloon Guide Catheter, Model 90031 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112262Reflex Ballon Guide CatheterReverse Medical Corporation20110—
+1K102657Concentric Balloon Guide CatheterConcentric Medical, Inc.201048—
+1K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc.20021861
+2K120781Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM LengthFuji Systems Corp.20124—
+2K112404Concentric Balloon Guide CatheterConcentric Medical, Inc.2012471
+2K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc.2006106—
+2K041151Kerberos Occluding Guide Catheter and AccessoriesKerberos Proximal Solutions, Inc.200425—
+3K223275CELLO II Balloon Guide CatheterFuji Systems Corporation20220—
+3K220331091 Balloon Guide CatheterInneuroco, Inc.20221—
+3K203723Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd.20212—
+3K133177Modified HD Guide CatheterConcentric Medical, Inc.2014283
+3K131492Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc.201313—
+3K122581Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc.2012151
+3K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+3K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc.20071051
+4K242392Path BGCCrossroads Neurovascular, Inc.20251—
+4K242301Socrates 38 CatheterScientia Vascular, Inc.20240—
+4K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)Penumbra, Inc.20240—
+4K231629091 Balloon Guide CatheterEosolutions, Corp.20230—
+4K221951Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd.20221—
+4K202916Balloon Guiding CatheterShanghai Heartcare Medical Technology Co., Ltd.20210—
+4K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical2016102
+4K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker2015263
+4K130649Silk Road Access CatheterSilk Road Medical, Inc.20131—
+4K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+4K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+4K111380Neuron Max SystemPenumbra, Inc.201161—
+4K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+4K102418Reverse Medical Report Guide Catheter SystemReverse Medical Corporation20111—
+4K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+4K100826Penumbra Catherer 025Penumbra, Inc.20102—
+4K093970Pica CatheterPenumbra, Inc.20105—
+4K082385Chaperon Guiding CatheterMicroVention, Inc.200817—
+4K083125Neuron Select Catheter Size 070Penumbra, Inc.2008861
+4K082290Neuron Delivery Catheter 070Penumbra, Inc.2008881
+5K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited20260—
+5K260938Path BGCCrossroads Neurovascular, Inc.20260—
+5K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd.20250—
+5K234115APRO 55 CatheterAlembic, LLC20244—
+5K233205Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd.20230—
+5K232437Paragon 8F Balloon Guide CatheterWallaby Medical20230—
+5K2226036F Wallaby Long SheathWallaby Medical, Inc.20230—
+5K222115ISAAC Neurovascular Navigation CatheterMicroVention, Inc.20231—
+5K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+5K221846Artix Ballon Guiding SheathInari Medical20220—
+5K212340EMBOGUARD Balloon Guide CatheterNeuravi Limited20211—
+5K193607BOBBY Balloon Guide CatheterMicroVention, Inc.202011
+5K201271Benchmark BMX96 Access SystemPenumbra, Inc.20201—
+5K200910BOSS Balloon Guide CatheterMarblehead Medical20201—
+5K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+5K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide…Medos International SARL20200Class I
+5K192525087 Balloon Guide Catheter SystemQ'Apel Medical, LLC20190—
+5K190749087 Balloon Guide Catheter SystemQ'Apel20190—
+5K182918Ballast 088 Long SheathBalt USA, LLC20191—
+5K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker201914—
+5K182097React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20182—
+5K180169EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access…Imperative Care, Inc.201827—
+5K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201819—
+5K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc.20160—
+5K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+5K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc.2016131
+5K151396MIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc.201512
+5K152401Stingray LP CatheterBoston Scientific Corporation20151—
+5K152840Lantern Delivery MicrocatheterPenumbra, Inc.20151—
+5K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+5K143459Silk Road Acccess CatheterSilk Road Medical, Inc.20150—
+5K142321Benchmark Intracranial Access SystemPenumbra, Inc.201516—
+5K140910Centercross CatheterRoxwood Medical, Inc.20143—
+5K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+5K131482Sofia Distal Access CatheterMicroVention, Inc.201311—
+5K122772Penumbra DDC CathetersPenumbra, Inc.20124—
+5K122795Stingray GuidewiresBridgepoint Medical201201
+5K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+5K120129Mantaray CatheterBridgepoint Medical20126—
+5K112629Onset Access Catheter SystemOnset Medical Corporation20110—
+6K261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo Neuro20260—
+6K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro20260—
+6K251097V-DAC CatheterVesalio, Inc.20260—
+6K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+6K251014APRO 45 CatheterAlembic, LLC20251—
+6K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+6K243297APRO 70 Swift CatheterAlembic, LLC20250—
+6K242376Next Generation Access PlatformBalt USA, LLC20240Class I
+6K242033Access25™ Delivery MicrocatheterPenumbra, Inc.20240—
+6K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—
+6K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+6K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited20240—
+6K231056Esperance Distal Access CatheterWallaby Medical20240—
+6K240030Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.20242—
+6K232679Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece…Argon Medical Devices, Inc.20241—
+6K231176Stingray LP CatheterBoston Scientific20230—
+6K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+6K213390Benchmark BMX96 Access SystemPenumbra, Inc.20220—
+6K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+6K212838Benchmark Intracranial Access SystemPenumbra, Inc.20227—
+6K220716Spartan SC 069Spartan Micro, Inc.20220—
+6K212224TracStar LDP Large Distal Platform; Zoom 88 Large Distal PlatformImperative Care, Inc.20216—
+6K203764TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal…Imperative Care, Inc.202117—
+6K203840BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC20210—
+6K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc.20200—