510(k) Report

Devices descending from K032660

120 later devices reach Xtrak Support Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005119—
+2K142065Turnpike CatheterVascular Solutions, Inc.20144—
+2K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+2K083833Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd.200912—
+2K081130Bridgepoint Medical Crossboss Percutaneous Coronary CatheterBridgepoint Medical200914—
+2K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.200933—
+2K082339Enabler-P Support CatheterEndocross, Ltd.200814—
+2K082519Finecross MG Coronary Micro-Guide CatheterTerumo Medical Corp.20089—
+2K062885Stride MicrocatheterAsahi Intecc Co., Ltd.200734—
+2K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+2K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd.200622—
+3K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+3K203521FineCross M3Ashitaka Factory of Terumo Corporation20210—
+3K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+3K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd.20187—
+3K171176M-CATH MicrocatheterAcrostak (Schweiz) AG20170—
+3K161126ASAHI Corsair ProAsahi Intecc Co., Ltd.201611—
+3K151896Houdini CatheterCruzar Medsystems, Inc.20151—
+3K151981Turnpike catheterVascular Solution, Inc.20152—
+3K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.201520—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K120964Upstream GR CatheterUpstream Peripheral Technologies20120—
+3K112035Valet Micro CatheterVolcano Corporation20129—
+3K113589Bigboss CatheterBridgepoint Medical20126—
+3K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+3K111263Cxi TriforceCook Incorporated20111—
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+3K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+3K092174Enabler-P Catheter System, Model 3000Endocross, Ltd.20099—
+3K091841Bridgepoint Medical Crossboss Catheter, Model M-2000Bridgepoint Medical200913—
+3K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+3K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+4K260559NHanceITIMDS Operation B.V.20260—
+4K213466Houdini Cross Support CatheterCruzar Medsystems, Inc.20220—
+4K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC20221—
+4K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC20220—
+4K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd.20210—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co., Ltd.20200—
+4K182420ASAHI Corsair Pro XSAsahi Intecc Co., Ltd.20180—
+4K182360Teleport MicrocatheterOrbusneich Medical Trading, Inc.20182—
+4K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+4K170664Odyssey Micro CatheterHeraeus Medical Components, LLC20170—
+4K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+4K152249ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20163—
+4K152447ASAHI CaravelAsahi Intecc Co., Ltd.20162—
+4K152401Stingray LP CatheterBoston Scientific Corporation20151—
+4K143744MicroCross CatheterRoxwood Medical, Inc.20151—
+4K141649Spex Support CatheterReflow Medical20146—
+4K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+4K122795Stingray GuidewiresBridgepoint Medical201201
+4K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+4K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+4K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+4K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+4K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+4K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+5K231608Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20241—
+5K231176Stingray LP CatheterBoston Scientific20230—
+5K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+5K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC20220—
+5K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+5K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+5K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+5K183357XableCath Crossing CatheterXablecath, Inc.20190—
+5K173560MicrocatheterSurmodics,Inc.20181—
+5K173662speX Support CatheterReflow Medical, Inc.20175—
+5K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+5K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20162—
+5K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+5K151082MicroCross CatheterRoxwood Medical, Inc.20150—
+5K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+5K140910Centercross CatheterRoxwood Medical, Inc.20143—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+5K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+5K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+5K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+5K111338Wildcat CatheterAvinger, Inc.201117—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd.20250—
+6K232647MicrocatheterSurmodics,Inc.20230—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+6K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+6K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18…Asahi Intecc Co., Ltd.20200—
+6K200094speX LP Support CatheterReflow Medical20201—
+6K193012speX Support CatheterReflow Medical20202—
+6K192782ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd.20190—
+6K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+6K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+6K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+6K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+6K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+6K122380Ocelot SystemAvinger, Inc.201214—
+6K113838Wildcat CatheterAvinger, Inc.20120—
+7K233350SINC Support CatheterReflow Medical, Inc.20240—
+7K210188coraCrossReflow Medical20210—
+7K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—