510(k) Report

Devices descending from K003483

41 later devices reach Modified Hydrophilic Coated Guidewire (Stainless Steel Core) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031842Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200340—
+2K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+2K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+2K033708Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20032—
+3K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+3K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+3K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+3K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+3K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+3K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+3K033929Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20041—
+4K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+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
+4K140288Truepath Cto DeviceBoston Scientific Corp20140—
+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—
+4K041973Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20040—
+5K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+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
+5K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+5K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+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—
+6K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+7K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+7K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+7K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+7K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+8K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+8K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+9K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—
+10K260244Auryon Atherectomy SystemEximo Medical20260—
+10K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.202401