510(k) Report

Devices descending from K001992

158 later devices reach Ilt 0.014 Catheter, Model C114NL2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082339Enabler-P Support CatheterEndocross, Ltd.200814—
+1K021802Stereotaxis Catheter Advancer SystemStereotaxis, Inc.20032—
+1K021638Ilt Advancing Mechanism, Model A115AMIIntra Luminal Therapeutics, Inc.20020—
+1K011562Lumend Percutaneous CatheterLumend, Inc.2002105—
+1K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism…Intra Luminal Therapeutics, Inc.2001123—
+2K120964Upstream GR CatheterUpstream Peripheral Technologies20120—
+2K092174Enabler-P Catheter System, Model 3000Endocross, Ltd.20099—
+2K083833Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd.200912—
+2K081130Bridgepoint Medical Crossboss Percutaneous Coronary CatheterBridgepoint Medical200914—
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+2K042850Cardiodrive, Model 001-004115 (Non-Sterile); 001-1169-1 (Sterile)Stereotaxis, Inc.20060—
+2K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.200580—
+2K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005119—
+2K051374Cardiodrive Catheter Advancement SystemStereotaxis, Inc.20050—
+2K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross…Intra Luminal Therapeutics, Inc.2003122—
+3K151896Houdini CatheterCruzar Medsystems, Inc.20151—
+3K142065Turnpike CatheterVascular Solutions, Inc.20144—
+3K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+3K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+3K113589Bigboss CatheterBridgepoint Medical20126—
+3K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+3K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+3K091841Bridgepoint Medical Crossboss Catheter, Model M-2000Bridgepoint Medical200913—
+3K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.200933—
+3K082337Minnie Support CatheterVascular Solutions, Inc.200935—
+3K082519Finecross MG Coronary Micro-Guide CatheterTerumo Medical Corp.20089—
+3K062885Stride MicrocatheterAsahi Intecc Co., Ltd.200734—
+3K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+3K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd.200622—
+3K032660Xtrak Support CatheterXtrak Medical, Inc.2003120—
+3K031417Ilt Safe Cross 0.035 Support Catheter, Model C135SN1Intra Luminal Therapeutics, Inc.20030—
+4K213466Houdini Cross Support CatheterCruzar Medsystems, Inc.20220—
+4K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+4K203521FineCross M3Ashitaka Factory of Terumo Corporation20210—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+4K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd.20187—
+4K171176M-CATH MicrocatheterAcrostak (Schweiz) AG20170—
+4K161126ASAHI Corsair ProAsahi Intecc Co., Ltd.201611—
+4K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+4K152401Stingray LP CatheterBoston Scientific Corporation20151—
+4K151981Turnpike catheterVascular Solution, Inc.20152—
+4K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.201520—
+4K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+4K140910Centercross CatheterRoxwood Medical, Inc.20143—
+4K141649Spex Support CatheterReflow Medical20146—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K130714Progigy Support CatheterRadius Medical, LLC20134—
+4K123311Qxmedical Access & Support CatheterQxmedical, LLC20134—
+4K122795Stingray GuidewiresBridgepoint Medical201201
+4K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K120129Mantaray CatheterBridgepoint Medical20126—
+4K112035Valet Micro CatheterVolcano Corporation20129—
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+4K111263Cxi TriforceCook Incorporated20111—
+4K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+4K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc.200914—
+4K092299Trailblazer Support CatheterEv3, Inc.200921
+4K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+4K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+5K260559NHanceITIMDS Operation B.V.20260—
+5K231176Stingray LP CatheterBoston Scientific20230—
+5K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+5K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC20221—
+5K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC20220—
+5K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd.20210—
+5K200317Support CatheterQxmedical, LLC20200—
+5K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+5K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co., Ltd.20200—
+5K183357XableCath Crossing CatheterXablecath, Inc.20190—
+5K182420ASAHI Corsair Pro XSAsahi Intecc Co., Ltd.20180—
+5K182360Teleport MicrocatheterOrbusneich Medical Trading, Inc.20182—
+5K173662speX Support CatheterReflow Medical, Inc.20175—
+5K170914TXM Support CatheterTexasmedical Technologies, Inc.20170—
+5K170931CXI TriForce Peripheral Crossing SetCook Incorporated20170—
+5K170664Odyssey Micro CatheterHeraeus Medical Components, LLC20170—
+5K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+5K170041XableCath Support CatheterXablecath, Inc.20171—
+5K160561Boosting CatheterQxmedical, LLC20160—
+5K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+5K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+5K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+5K152249ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20163—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+5K152447ASAHI CaravelAsahi Intecc Co., Ltd.20162—
+5K143744MicroCross CatheterRoxwood Medical, Inc.20151—
+5K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+5K112100M2 Navigation Catheter and Guideliner Navigation CatheterVascular Solutions, Inc.20120—
+5K112082Guideliner V2 CatheterVascular Solutions, Inc.2011121
+5K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+5K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+5K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+5K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K231608Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20241—
+6K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC20220—
+6K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—