510(k) Report

Devices descending from K991059

165 later devices reach Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+5K111338Wildcat CatheterAvinger, Inc.201117—
+5K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+5K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+5K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+5K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+5K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+5K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+5K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp.2007221
+5K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp.200523—
+6K252390Telescope Guide Extension CatheterMedtronic, Ireland20250—
+6K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+6K242337FlowGuide (FG60F); GuidionShort (GS60F)Imds Operations B.V.20250—
+6K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc.20250—
+6K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)Vantis Vascular, Inc.20241—
+6K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+6K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc20220—
+6K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+6K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+6K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+6K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+6K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+6K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+6K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+6K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+6K151981Turnpike catheterVascular Solution, Inc.20152—
+6K140288Truepath Cto DeviceBoston Scientific Corp20140—
+6K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+6K122380Ocelot SystemAvinger, Inc.201214—
+6K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+6K113838Wildcat CatheterAvinger, Inc.20120—
+6K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+6K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+7K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.20260—
+7K260559NHanceITIMDS Operation B.V.20260—
+7K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+7K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+7K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+7K212047Pantheris SystemAvinger, Inc.20210—
+7K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+7K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+7K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+7K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+7K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+7K123462Ocelot CatheterAvinger, Inc.20120—
+7K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+8K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+8K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+8K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+8K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+8K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+8K152275Pantheris SystemAvinger, Inc.20156—
+8K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+9K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+9K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+9K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+9K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+9K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+9K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+9K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+10K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+10K173862Pantheris SystemAvinger, Inc.20181—
+10K160827Pantheris CatheterAvinger, Inc.20164—
+11K260244Auryon Atherectomy SystemEximo Medical20260—
+11K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401