510(k) Report

Devices descending from K982083

194 later devices reach Acs HI-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC20220—
+5K213949VASSALLO GT 018 FloppyFilmecc Co., Ltd.20220—
+5K171897Approach CTO Microwire GuideCook Incorporated201703
+5K151234R350 guidewireVascular Solutions, Inc.20155—
+5K122795Stingray GuidewiresBridgepoint Medical201201
+5K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+5K101729Neowire Pta/Ptca GuidewireNeometrics, Inc.20100—
+5K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc.200731—
+5K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+5K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+5K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200418—
+5K033708Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20032—
+6K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+6K161702Endura guidewireVascular Solutions, Inc.20164—
+6K152401Stingray LP CatheterBoston Scientific Corporation20151—
+6K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+6K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+6K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+6K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+6K091254The Crosser 14 Otw Catheter, Model CRU014Flowcardia, Inc.20090—
+6K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+6K080765Crosser LP SystemFlowcardia, Inc.20087—
+6K072776The Crosser SystemFlowcardia, Inc.2007281
+6K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+6K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+6K050916Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]Intra Luminal Therapeutics, Inc.200516—
+6K050915Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]Intra Luminal Therapeutics, Inc.20051—
+6K033929Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20041—
+7K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+7K231176Stingray LP CatheterBoston Scientific20230—
+7K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+7K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+7K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+7K183357XableCath Crossing CatheterXablecath, Inc.20190—
+7K163444Spectre guidewireVascular Solutions, Inc.20173—
+7K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+7K140288Truepath Cto DeviceBoston Scientific Corp20140—
+7K122380Ocelot SystemAvinger, Inc.201214—
+7K121745Mantaray GuidewiresBridgepoint Medical20120—
+7K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+7K111338Wildcat CatheterAvinger, Inc.201117—
+7K092175The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200Flowcardia, Inc.20106—
+7K091119Modification to the Crosser SystemFlowcardia, Inc.20095—
+7K073162Safe-Cross (R) Radio Frequency Total Occlusion Crossing System, Safe-Cross (R) Radio…Kensey Nash Corporation20080—
+7K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp.2007221
+7K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp.200523—
+7K041973Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20040—
+8K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+8K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+8K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc20220—
+8K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc.20202—
+8K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+8K180128Warrior 14 guidewireVascular Solutions, Inc.20180—
+8K173532Raider GuidewireVascular Solutions, Inc.20171—
+8K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+8K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+8K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+8K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+8K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+8K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+8K123462Ocelot CatheterAvinger, Inc.20120—
+8K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+8K113838Wildcat CatheterAvinger, Inc.20120—
+8K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+9K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+9K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+9K212047Pantheris SystemAvinger, Inc.20210—
+9K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+9K210839SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc.20211—
+9K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+9K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+9K181647Bandit guidewireVascular Solutions, Inc.20180—
+9K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+9K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+9K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+9K152275Pantheris SystemAvinger, Inc.20156—
+9K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+10K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.20230—
+10K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+10K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+10K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+10K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+10K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+10K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+10K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+10K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+10K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+11K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+11K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+11K173862Pantheris SystemAvinger, Inc.20181—
+11K160827Pantheris CatheterAvinger, Inc.20164—
+12K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+13K260244Auryon Atherectomy SystemEximo Medical20260—
+13K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401