510(k) Report

Devices descending from K013284

72 later devices reach Lumend Frontrunner Cto Coronary Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+1K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+1K023114Lumend Frontrunner Cto CatheterLumend, Inc.200369—
+2K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+2K171897Approach CTO Microwire GuideCook Incorporated201703
+2K152401Stingray LP CatheterBoston Scientific Corporation20151—
+2K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+2K122795Stingray GuidewiresBridgepoint Medical201201
+2K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+2K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+2K031005Lumend Frontrunner GW Cto CatheterLumend, Inc.200332—
+3K231176Stingray LP CatheterBoston Scientific20230—
+3K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+3K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+3K183357XableCath Crossing CatheterXablecath, Inc.20190—
+3K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+3K121745Mantaray GuidewiresBridgepoint Medical20120—
+3K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+3K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+3K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+3K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc.200431—
+4K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+4K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.20250—
+4K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+4K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+4K111338Wildcat CatheterAvinger, Inc.201117—
+4K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+4K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+4K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+4K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp.2007221
+4K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp.200523—
+5K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+5K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc20220—
+5K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+5K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+5K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+5K140288Truepath Cto DeviceBoston Scientific Corp20140—
+5K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+5K122380Ocelot SystemAvinger, Inc.201214—
+5K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+5K113838Wildcat CatheterAvinger, Inc.20120—
+5K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+6K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+6K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+6K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+6K212047Pantheris SystemAvinger, Inc.20210—
+6K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+6K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+6K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+6K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+6K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+6K123462Ocelot CatheterAvinger, Inc.20120—
+6K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+7K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+7K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+7K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+7K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+7K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+7K152275Pantheris SystemAvinger, Inc.20156—
+7K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+8K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+8K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+8K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+8K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+8K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+8K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+8K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+9K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+9K173862Pantheris SystemAvinger, Inc.20181—
+9K160827Pantheris CatheterAvinger, Inc.20164—
+10K260244Auryon Atherectomy SystemEximo Medical20260—
+10K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401