510(k) Report

Devices descending from K043553

79 later devices reach Silverhawk Peripheral Plaque Excision System, Models 02550,04800, 05200… 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—
+1K071350Diamondback 360 Degree Orbital Atherectomy SystemCardiovascular Systems, Inc.200728—
+1K053460Modification to Silverhawk Peripheral Plaque Excision System, Models 02550, 04800…Fox Hollow Technologies200652—
+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—
+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—
+2K061188Silverhawk Peripheral Plaque Excision SystemFoxhollow Technologies, Inc.2006501
+2K061063Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/FG08300Foxhollow Technologies, Inc.200637—
+3K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20233—
+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—
+3K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMedtronic Vascular, Inc.20171—
+3K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.201583
+3K152275Pantheris SystemAvinger, Inc.20156—
+3K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System…Cardiovascular System, Inc.201512
+3K150732Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20152—
+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
+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—
+3K103618Turbohawk Peropheral Plaque Excision SystemEv3, Inc.20114—
+3K093456Jetstream G3 SystemPathway Medical Technologies, Inc.200924—
+3K093301Turbohawk Peripheral Plaque Excision SystemEv3, Inc.20096—
+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—
+3K071432Silverhawk-R Peripheral Plaque Excision System for Surgical UseFox Hollow Technologies20080—
+4K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,20241—
+4K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow Inc.,20242—
+4K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P.20210—
+4K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.20210Class I
+4K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy…Volcano Atheromed, Inc.20210—
+4K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascular Systems, Inc.201942
+4K182397Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable SeriesCardiovascular Systems, Inc.20183—
+4K180416ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD)…Cardiovascular Systems, Inc.20180—
+4K172315Straub Endovascular SystemStraub Medical AG20182Class I
+4K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.20171—
+4K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+4K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc.20161—
+4K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+4K141801Hawkone Directional Atherectomy SystemCovidien, LLC20141—
+4K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc.201141
+5K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…Cardio Flow Inc.,20250—
+5K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20220—
+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
+5K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral…Cardiovascular Systems, Inc.20201—
+5K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+5K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc.20160Class I
+5K160827Pantheris CatheterAvinger, Inc.20164—
+6K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+6K220568Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital…Cardiovascualr Systems, Inc.20220—
+6K173862Pantheris SystemAvinger, Inc.20181—
+7K212047Pantheris SystemAvinger, Inc.20210—