510(k) Report

Devices descending from K901206

102 later devices reach Rotablator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191419Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireRex Medical, L.P.20191—
+1K133566Rotablator Rotational Atherectomy System with the Peripheral Rotalink PlusBoston Scientific Corp20131—
+1K081328Pathway PV Atherectomy SystemPathway Medical Technologies, Inc.200834—
+1K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.200728—
+1K041630Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems Incorporated200530—
+1K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+2K220962ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation20220—
+2K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P.20210—
+2K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+2K132682Phoenix 5F Tracking Atherectomy Catheter, Phoenix 6F Tracking Atherectomy Catheter…Atheromed, Inc.20146—
+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—
+2K111388Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad SystemCardiovascular Systems, Inc.20110—
+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—
+2K110389Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.2011201
+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—
+2K090521Diamondback 360 DBXCardiovascular Systems, Inc.2009242
+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—
+2K081944Modification to Diamondback 360 Degree Orbital Atherectomy SystemCardio Systems, Inc.200825—
+2K072748Modification to: Diamondback 360 Orbital Atherectomy SystemCardiovascular Systems, Inc.200726—
+2K072800Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.20070—
+2K071427Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt StenosisCardiovascular Systems, Inc.2007282
+2K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+2K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+2K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+3K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20233—
+3K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+3K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.20180—
+3K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.201583
+3K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…Cardiovascular System, Inc.201512
+3K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemVolcano Atheromed, Inc.20152—
+3K150732Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20152—
+3K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc.201431
+3K1409441.8 MM Phoenix Atherectomy Catheter, 2.2 MM Phoenix Atherectomy Catheter, Phoenix…Atheromed, Inc.20145—
+3K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+3K133999Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20140—
+3K133399Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated20134Class I
+3K131092Stealth 360 Orbital Pad SystemCardio Systems, Inc.20135—
+3K122987Stealth 360 Orbital Pad SystemCardiovascular Systems, Inc.20126—
+3K112308Crosser Recanalization SystemC.R. Bard, Inc.20112—
+3K101599RVT Cto DeviceRevascular Therapeutics, Inc.20111—
+3K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc.20102—
+3K093456Jetstream G3 SystemPathway Medical Technologies, Inc.200924—
+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—
+3K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+3K071227Clirpath Turbo Excimer Laser Catheter (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX)…Spectranetics Corp.2007221
+3K052514Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156…Spectranetics Corp.200523—
+4K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20241—
+4K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20241—
+4K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,20242—
+4K220544DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)Ra Medical Systems,Inc20220—
+4K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc.201942
+4K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.20181—
+4K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.20183—
+4K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+4K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc.20180—
+4K172315Straub Endovascular SystemStraub Medical AG20182Class I
+4K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System…Volcano Atheromed, Inc.20172—
+4K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, 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
+4K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy…Volcano Atheromed, Inc.20143—
+4K140288Truepath Cto DeviceBoston Scientific Corp20140—
+4K1236322.5MM Turbo Elite 035, 2.3MM Turbo Elite 035Spectranetics Corp.201301
+4K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+5K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.20250—
+5K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…Cardio Flow Inc.,20250—
+5K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+5K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+5K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+5K212047Pantheris SystemAvinger, Inc.20210—
+5K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+5K210586Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital…Cardiovascular Systems, Inc.20210—
+5K203363Crosser iQ CTO Recanalization SystemC.R. Bard, Inc.202101
+5K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+5K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+5K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+5K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+5K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+5K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+6K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+6K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+6K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+6K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—
+6K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+6K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+7K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+7K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+8K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…Eximo Medical, Ltd.20232—