510(k) Report

Devices descending from K913517

95 later devices reach Isolate Infusion Cathetr System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081147Isoflow Infusion CatheterVascular Designs, Inc.20091—
+1K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc.20068—
+1K041517InfusioncathId, LLC20043—
+1K040139Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc.20049—
+1K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed20036—
+1K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc.200275—
+2K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.20164—
+2K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.20165—
+2K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+2K140637Peregrine System Infusion CatheterAblative Solutions, Inc.20146—
+2K130569ND Nabil Dib Infusion CatheterTranslational Research Institute20130—
+2K071468Clarivein CatheterVascular Insights, LLC200841
+2K073400Varicath Peripheral Infusion CatheterVeinrx, Inc.20070—
+2K052844Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG20060—
+2K052738Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028…Veinrx, Inc.20051—
+2K042117Proxis System, Model Eps 101Velocimed, Inc.20055—
+2K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc.2002561
+2K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc.2002571
+3K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.20230—
+3K222185Stratus Infusion CatheterIntervene, Inc.20230—
+3K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB20221—
+3K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+3K210339Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.20210—
+3K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+3K153502ClariVein ICVascular Insights, LLC20163—
+3K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+3K060651Proxis System, Model EPS101St Jude Medical20063—
+3K052523Proxis SystemVelocimed, Inc.20062—
+3K032261Trellis Reserve Infusion SystemBacchus Vascular, Inc.20036—
+3K030637Ekos Peripheral Infusion SystemEkos Corp.200350—
+4K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB20260—
+4K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+4K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+4K223891Cobra Catheter SystemEndovascular Engineering20232—
+4K201907ClariVein ICMerit Medical Systems, Inc.20202—
+4K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+4K073563Modification to Proxis SystemSt Jude Medical20080—
+4K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+4K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc.20055—
+4K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+4K033214Ekos Peripheral Infusion SystemEkos Corp.200346—
+5K250794InVera Infusion DeviceInvera Medical20260—
+5K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+5K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical, Ltd.20230—
+5K130904Trellis-8 Peripheral Infusion SystemCovidien20130Class I
+5K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+5K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+5K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc.20071Class I
+5K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+5K050563Ekos Peripheral Infusion SystemEkos Corp.200521—
+5K041629Lysus Infusion SystemEkos Corp.200439—
+6K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+6K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+6K082199Spiralfuse Peripheral Infusion SystemBacchus Vascular, Inc.20080—
+6K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+6K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+6K050472Lysus Infusion SystemEkos Corp.20050—
+6K042456Lysus Infusion SystemEkos Corp.2004383
+7K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+7K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+7K062507Micro-Infusion SystemEkos Corp.200613—
+7K051319Lysus Infusion SystemEkos Corp.200535—
+7K043269Lysus Infusion SystemEkos Corp.20040—
+8K080392EndoWave Infusion SystemEkos Corp.200811—
+8K073166Endowave Infusion SystemEkos Corp.200811—
+8K052071Lysus Infusion SystemEkos Corp.200534—
+9K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+9K060422Lysus Infusion SystemEkos Corp.2006271
+9K060084Lysus Infusion SystemEkos Corp.200617—
+10K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+10K111705Ekosonic Endovascular SystemEkos Corporation201195
+10K072507Endowave Infusion SystemEkos Corp.2007133
+10K071933Endowave Infusion SystemEkos Corp.200712—
+11K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+11K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+11K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+12K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+12K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+12K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+12K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+12K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+12K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+12K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+12K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+13K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+13K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+13K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+13K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+13K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+14K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—
+14K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+14K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+14K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+14K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+15K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—