510(k) Report

Devices descending from K024243

116 later devices reach Reform Peripheral Catheter System, Model 02200; Reform Peripheral… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc.20146—
+1K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.200834—
+1K043553Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200, 02406, 04706…Fox Hollow Technologies200579—
+1K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+2K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+2K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc.20152—
+2K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc.20145—
+2K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…Medrad, Inc.20135—
+2K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…Medrad, Inc.20126—
+2K120242Jetstream Navitus L SystemPathway Medical Technologies, Inc.201214—
+2K111229Jetstream G3 (R) SF 1.6 SystemPathway Medical Technologies, Inc.201115—
+2K110626Jetstream Navitus System; Jetstream G3 SF System; Jetstream G3 SE System; Jetstream G3 L…Pathway Medical Technologies, Inc.201110—
+2K101334Jetstream G3 SE System, Jetstream G3 SF System Model PV31230 (Jetstream G3 SE Catheter…Pathway Medical Technologies, Inc.201020—
+2K101221Jetstream G3 System, Model PV31300, PV Console, Model PVCN100Pathway Medical Technologies, Inc.201019—
+2K100462Jetstream G3 L System, PV Console, Models PV31400, PV31300, PVCN100Pathway Medical Technologies, Inc.201022—
+2K093918Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100…Pathway Medical Technologies, Inc.201023—
+2K092332Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100…Pathway Medical Technologies, Inc.200925—
+2K091509Jetstream G2 NXT System, Model PV20300Pathway Medical Technologies, Inc.200926—
+2K083489Jetstream Pathway PC Atherectomy System, Model OV10300Pathway Medical Technologies, Inc.200928—
+2K082664Jetstream Pathway PV Atherectomy System, Model PV10300, PVCN100Pathway Medical Technologies, Inc.200832—
+2K082186Modification to Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.200833—
+2K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.200728—
+2K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+2K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Fox Hollow Technologies200652—
+2K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+2K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+3K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+3K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireRex Medical, L.P.20191—
+3K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—
+3K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+3K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc.20172—
+3K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…Volcano Atheromed, Inc.20143—
+3K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+3K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+3K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+3K111388Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad SystemCardiovascular Systems, Inc.20110—
+3K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.2011201
+3K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+3K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+3K093456Jetstream G3 SystemPathway Medical Technologies, Inc.200924—
+3K090521Diamondback 360 DBXCardiovascular Systems, Inc.2009242
+3K090325Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200927—
+3K083837Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV…Pathway Medical Technologies, Inc.200928—
+3K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc.200825—
+3K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+3K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc.200726—
+3K072800Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.20070—
+3K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp.2007221
+3K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc.2006501
+3K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc.200637—
+3K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp.200523—
+4K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+4K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20233—
+4K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc20220—
+4K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P.20210—
+4K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+4K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+4K172315Straub Endovascular SystemStraub Medical AG20182Class I
+4K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMedtronic Vascular, Inc.20171—
+4K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+4K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+4K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+4K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.201583
+4K152275Pantheris SystemAvinger, Inc.20156—
+4K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…Cardiovascular System, Inc.201512
+4K150732Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20152—
+4K140288Truepath Cto DeviceBoston Scientific Corp20140—
+4K133999Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20140—
+4K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated20134Class I
+4K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc.20135—
+4K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+4K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.20126—
+4K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc.20114—
+4K093301Turbohawk Peripheral Plaque Excision SystemEv3, Inc.20096—
+4K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+4K071432Silverhawk-R Peripheral Plaque Excision System for Surgical UseFox Hollow Technologies20080—
+5K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+5K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+5K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20241—
+5K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,20242—
+5K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+5K212047Pantheris SystemAvinger, Inc.20210—
+5K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+5K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.20210Class I
+5K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+5K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+5K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc.201942
+5K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.20183—
+5K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc.20180—
+5K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+5K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20171—
+5K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+5K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+5K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+5K141801Hawkone Directional Atherectomy SystemCovidien, LLC20141—
+5K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc.201141
+5K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+6K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…Cardio Flow Inc.,20250—
+6K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+6K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—