510(k) Report

Devices descending from K011986

76 later devices reach Safe-Steer Guide Wire System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021323Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc.200275—
+2K032031Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200436—
+2K031842Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200340—
+3K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc.200731—
+3K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+3K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+3K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200418—
+3K033708Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20032—
+4K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+4K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+4K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+4K091254The Crosser 14 Otw Catheter, Model CRU014Flowcardia, Inc.20090—
+4K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+4K080765Crosser LP SystemFlowcardia, Inc.20087—
+4K072776The Crosser SystemFlowcardia, Inc.2007281
+4K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+4K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+4K050916Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]Intra Luminal Therapeutics, Inc.200516—
+4K050915Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]Intra Luminal Therapeutics, Inc.20051—
+4K033929Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20041—
+5K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+5K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+5K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+5K140288Truepath Cto DeviceBoston Scientific Corp20140—
+5K122380Ocelot SystemAvinger, Inc.201214—
+5K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+5K111338Wildcat CatheterAvinger, Inc.201117—
+5K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc.20106—
+5K091119Modification to the Crosser SystemFlowcardia, Inc.20095—
+5K073162Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio…Kensey Nash Corporation20080—
+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—
+5K041973Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20040—
+6K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+6K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc20220—
+6K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc.20202—
+6K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+6K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+6K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+6K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+6K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+6K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+6K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+6K123462Ocelot CatheterAvinger, Inc.20120—
+6K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+6K113838Wildcat CatheterAvinger, Inc.20120—
+6K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+7K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+7K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+7K212047Pantheris SystemAvinger, Inc.20210—
+7K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+7K210839SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc.20211—
+7K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+7K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+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—
+7K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+7K152275Pantheris SystemAvinger, Inc.20156—
+7K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+8K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.20230—
+8K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+8K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+8K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+8K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+8K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+8K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+8K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+8K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+8K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+9K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+9K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+9K173862Pantheris SystemAvinger, Inc.20181—
+9K160827Pantheris CatheterAvinger, Inc.20164—
+10K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+11K260244Auryon Atherectomy SystemEximo Medical20260—
+11K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401