510(k) Report

Devices descending from K000177

72 later devices reach Renegade HI-Flo Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140329Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom KitBoston Scientific20140—
+1K113778Excelsior XT-27 MicrocatheterStryker Neurovascular201283
+1K112690Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd.20120—
+1K112124MicrocatheterNavilyst Medical, Inc.20112—
+1K100892Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp20107—
+1K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+1K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+1K030637Ekos Peripheral Infusion SystemEkos Corp.200350—
+2K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…Stryker Neurovascular20250—
+2K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.201331
+2K132947Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp20135—
+2K130858Reverse Medical MicrocatheterReverse Medical Corporation20131—
+2K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20134—
+2K121954Nmi MicrocatheterNavilyst Medical, Inc.20120—
+2K113638Nmi 2.8 MicrocatheterNavilyst Medical, Inc.20120—
+2K073166Endowave Infusion SystemEkos Corp.200811—
+2K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+2K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+2K033214Ekos Peripheral Infusion SystemEkos Corp.200346—
+3K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+3K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20170—
+3K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+3K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+3K142259Direxion Torqueable MicrocatheterBoston Scientific Corp20144—
+3K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+3K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+3K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+3K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+3K050563Ekos Peripheral Infusion SystemEkos Corp.200521—
+3K041629Lysus Infusion SystemEkos Corp.200439—
+4K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation2017341
+4K111705Ekosonic Endovascular SystemEkos Corporation201195
+4K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+4K062507Micro-Infusion SystemEkos Corp.200613—
+4K050472Lysus Infusion SystemEkos Corp.20050—
+4K042456Lysus Infusion SystemEkos Corp.2004383
+5K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…Transit Scientific, LLC20230—
+5K201792TRUSELECT MicrocatheterBoston Scientific Corporation20201—
+5K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+5K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K080392EndoWave Infusion SystemEkos Corp.200811—
+5K051319Lysus Infusion SystemEkos Corp.200535—
+5K043269Lysus Infusion SystemEkos Corp.20040—
+6K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation20260—
+6K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+6K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+6K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+6K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+6K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+6K052071Lysus Infusion SystemEkos Corp.200534—
+7K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+7K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+7K060422Lysus Infusion SystemEkos Corp.2006271
+7K060084Lysus Infusion SystemEkos Corp.200617—
+8K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—
+8K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+8K072507Endowave Infusion SystemEkos Corp.2007133
+8K071933Endowave Infusion SystemEkos Corp.200712—
+9K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+9K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+10K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+10K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+10K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+11K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+11K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+11K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+12K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+12K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+12K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+12K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+13K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—