FDA 510(k) Applications for Medical Device Product Code "KRA"
(Catheter, Continuous Flush)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K140637 | ABLATIVE SOLUTIONS, INC. | PEREGRINE SYSTEM INFUSION CATHETER | 03/26/2014 |
| K231279 | Ablative Solutions, Inc. | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | 07/05/2023 |
| K023351 | ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC | MAGIC INFUSION CATHETER | 02/20/2003 |
| K211110 | Agile Devices, Inc. | Agile Devices Angler Steerable, Deflectable Microcatheter | 01/07/2022 |
| K070384 | ARGON MEDICAL DEVICES INC. | ARGON CONTINUOUS FLUSH DEVICE | 03/29/2007 |
| K223176 | Argon Medical Devices, Inc. | Cleaner PlusÖ Thrombectomy System, Cleaner PlusÖ Aspiration Catheter, Cleaner PlusÖ Handpiece with 65cm Maceration Wire, Cleaner PlusÖ Handpiece with 135cm Maceration Wire, Cleaner PlusÖ Aspiration Canister | 04/10/2023 |
| K213435 | Balt USA, LLC | MAGIC Flow-Dependent Microcatheter | 07/19/2022 |
| K202366 | Balt USA, LLC | MAGIC Infusion Catheter | 01/29/2021 |
| K200582 | Bend It Technologies Ltd. | Bendit2.7 Steerable Microcatheter | 06/25/2020 |
| K140329 | BOSTON SCIENTIFIC | RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT | 05/15/2014 |
| K050630 | BOSTON SCIENTIFIC - PRECISION VASCULAR | PIVOT STEERABLE MICROCATHETER | 03/22/2005 |
| K132947 | BOSTON SCIENTIFIC CORP. | DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS | 10/18/2013 |
| K142259 | BOSTON SCIENTIFIC CORP. | Direxion Torqueable Microcatheter | 09/10/2014 |
| K963988 | BOSTON SCIENTIFIC CORP. | INTRAVASCULAR INFUSION DEVICE | 12/12/1996 |
| K973645 | BOSTON SCIENTIFIC CORP. | RENEGADE FIBER BRAIDED MICROCATHETER | 11/19/1997 |
| K100892 | BOSTON SCIENTIFIC CORP. | RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX | 04/12/2010 |
| K000177 | BOSTON SCIENTIFIC CORP. | RENEGADE HI-FLO MICROCATHETER | 04/07/2000 |
| K163701 | BOSTON SCIENTIFIC CORPORATION | Direxion and Direxion HI-FLO Torqueable Microcatheters | 05/16/2017 |
| K201792 | Boston Scientific Corporation | TRUSELECT Microcatheter | 07/28/2020 |
| K994155 | BOSTON SCIENTIFIC, TARGET | EXCELSIOR 1018 MICROCATHETER | 08/03/2000 |
| K161967 | Callisyn Biomedical, Inc. | FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm | 01/27/2017 |
| K091559 | CHESTNUT MEDICAL TECHNOLOGIES, INC. | MARKSMANN CATHETER | 09/18/2009 |
| K161801 | Cook Incorporated | CrossCath Support Catheter | 07/29/2016 |
| K160884 | COOK INCORPORATED | CXI Support Catheter | 11/22/2016 |
| K111263 | COOK INCORPORATED | CXI TRIFORCE | 07/25/2011 |
| K170931 | Cook Incorporated | CXI TriForce Peripheral Crossing Set | 11/13/2017 |
| K060224 | COOK INCORPORATED | MODIFICATION TO MIRA-FLEX 18 MICROCATHETER | 03/06/2006 |
| K182071 | Cook Incorporated | Multi-Sideport Catheter Infusion Set | 04/25/2019 |
| K101450 | COOK, INC. | CANTATA MICROCATHETER | 12/30/2010 |
| K131772 | COOK, INC. | CANTATA(R) 2.9 MICROCATHETER | 02/20/2014 |
| K093052 | COOK, INC. | CROSSCATH SUPPORT CATHTER | 12/08/2009 |
| K122796 | COOK, INC. | CXI SUPPORT CATHETER | 10/11/2012 |
| K072724 | COOK, INC. | CXI SUPPORT CATHETER | 11/09/2007 |
| K961668 | COOK, INC. | MICROFERRET CATHETER | 11/04/1996 |
| K052841 | COOK, INC. | MIRA-FLEX 18 MICROCATHETER | 12/08/2005 |
| K080737 | COOK, INC. | MIRAFLEX HIGH FLOW MICROCATHETER | 08/08/2008 |
| K983003 | CORDIS NEUROVASCULAR, INC. | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS | 09/17/1998 |
| K965181 | CORDIS NEUROVASCULAR, INC. | CES INFUSION CATHETER | 03/21/1997 |
| K974222 | CORDIS NEUROVASCULAR, INC. | CES MASSTRANSIT INFUSION CATHETER | 02/10/1998 |
| K971306 | CORDIS NEUROVASCULAR, INC. | FG INFUSION CATHETER | 07/14/1997 |
| K043538 | CORDIS NEUROVASCULAR, INC. | HYPERTRANSIT INFUSION CATHETER | 04/18/2005 |
| K070279 | CORDIS NEUROVASCULAR, INC. | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER | 03/14/2007 |
| K003925 | CORDIS NEUROVASCULAR, INC. | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS | 01/08/2001 |
| K993266 | CORDIS NEUROVASCULAR, INC. | PROWLER PLUS INFUSION CATHETER | 10/28/1999 |
| K021591 | CORDIS NEUROVASCULAR, INC. | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | 05/22/2002 |
| K020680 | CORDIS NEUROVASCULAR, INC. | PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | 03/27/2002 |
| K972518 | CORDIS NEUROVASCULAR, INC. | TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER | 11/04/1997 |
| K971619 | E-MED CORP. | MICROFUSE MEMBRANE INFUSION CATHETER | 02/27/1998 |
| K180275 | Edwards Lifesciences LLC | VAMP Optima closed blood sampling system | 10/24/2018 |
| K161962 | Edwards Lifesciences LLC | VAMP Venous/Arterial Blood Management Protection System | 11/28/2016 |
| K181684 | Edwards Lifesciences, LLC | VAMP Plus Venous/Arterial Blood Management Protection System | 11/08/2018 |
| K173586 | Edwards Lifesciences, LLC | VAMP Venous/Arterial Blood Management Protection System | 04/05/2018 |
| K073166 | EKOS CORP. | ENDOWAVE INFUSION SYSTEM | 04/22/2008 |
| K040139 | ENDOBIONICS, INC. | ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER | 02/18/2004 |
| K093750 | EV3 INC | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA | 12/09/2009 |
| K111490 | EV3 INC | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS | 09/16/2011 |
| K050205 | FLOWMEDICA, INC. | BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH | 03/04/2005 |
| K082163 | FLOWMEDICA, INC. | FLOWMEDICA BENEPHIT INFUSION SYSTEMS | 10/29/2008 |
| K033569 | FLOWMEDICA, INC. | FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH | 01/13/2004 |
| K191305 | Heraeus Medical Components, LLC | Hereaeus Poseidon Microcatheter | 12/19/2019 |
| K070979 | ICU MEDICAL, INC | PULL TAB SQUEEZE FLUSH | 09/19/2007 |
| K200744 | Instylla, Inc. | Instylla Microcatheter | 04/21/2020 |
| K191731 | Instylla, Inc. | Instylla Microcatheter | 08/13/2019 |
| K210808 | Instylla, Inc. | Instylla Microcatheter 1.2 | 04/15/2021 |
| K955534 | INTERNATIONAL INNOVATIONS, INC. | SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) | 08/01/1996 |
| K955525 | INTERVENTIONAL INNOVATIONS CORP. | FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 | 08/08/1996 |
| K964154 | INTERVENTIONAL INNOVATIONS CORP. | SEGUE INFUSION CATHETER | 01/14/1997 |
| K961527 | MEDEX, INC. | MX703 AND MX730 CONTINUOUS FLUSH DEVICES | 06/06/1996 |
| K954457 | MEDI-TECH, INC. | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | 05/15/1996 |
| K214025 | Medos International Sarl | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | 04/12/2022 |
| K210838 | Medos International SARL | PROWLER SELECT PLUS; PROWLER EX | 08/25/2021 |
| K161402 | MERCATOR MEDSYSTEMS, INC. | Bullfrog Micro-Infusion Device | 08/18/2016 |
| K210339 | Mercator MedSystems, Inc. | Bullfrog Micro-Infusion Device | 08/02/2021 |
| K153501 | MERCATOR MEDSYSTEMS, INC. | Bullfrog Micro-Infusion Device | 04/15/2016 |
| K062752 | MERCATOR MEDSYSTEMS, INC. | MERCATOR MICROSYRINGE II INFUSION CATHETER | 12/07/2006 |
| K230636 | Merit Medical System, Inc. | Maestro Microcatheter | 03/30/2023 |
| K193082 | Merit Medical Systems, Inc | Fountain ValveTip Infusion Catheter | 08/07/2020 |
| K201907 | Merit Medical Systems, Inc. | ClariVein IC | 08/06/2020 |
| K962129 | MERIT MEDICAL SYSTEMS, INC. | CONTINUOUS FLUSH DEVICE | 04/15/1997 |
| K172081 | Merit Medical Systems, Inc. | Maestro Microcatheter | 08/04/2017 |
| K082613 | MERIT MEDICAL SYSTEMS, INC. | MERIT MICROCATHETER | 12/30/2008 |
| K161921 | MERIT MEDICAL SYSTEMS, INC. | SwiftNINJA Microcatheter | 11/04/2016 |
| K211525 | Merit Medical Systems, Inc. | SwiftNINJA Steerable Microcatheter | 07/16/2021 |
| K210114 | Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular | Rebar Micro Catheter | 02/16/2021 |
| K964868 | MICRO THERAPEUTICS, INC. | 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER | 05/20/1997 |
| K974473 | MICRO THERAPEUTICS, INC. | EASY RIDER MICRO CATHETER | 06/17/1998 |
| K042187 | MICRO THERAPEUTICS, INC. | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 | 09/02/2004 |
| K051990 | MICRO THERAPEUTICS, INC. | ECHELON MICRO CATHETER | 01/04/2006 |
| K031992 | MICRO THERAPEUTICS, INC. | ECHELON MICRO CATHETER, MODEL 105-5091 | 08/07/2003 |
| K030688 | MICRO THERAPEUTICS, INC. | ECHELON MICRO CATHETER, MODEL 105-5092-150 | 03/28/2003 |
| K090870 | MICRO THERAPEUTICS, INC. | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY | 05/01/2009 |
| K980104 | MICRO THERAPEUTICS, INC. | FLOW RIDER FLOW DIRECTED MICRO CATHETER | 04/10/1998 |
| K010004 | MICRO THERAPEUTICS, INC. | FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 | 02/13/2001 |
| K034036 | MICRO THERAPEUTICS, INC. | MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 | 02/13/2004 |
| K954020 | MICRO THERAPEUTICS, INC. | MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE | 01/02/1996 |
| K024122 | MICRO THERAPEUTICS, INC. | NAUTICA MICRO CATHETER, MODEL 105-5094-153 | 03/07/2003 |
| K113289 | MICRO THERAPEUTICS, INC. | ORION MICRO CATHETER | 08/01/2012 |
| K993672 | MICRO THERAPEUTICS, INC. | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 | 01/04/2000 |
| K002723 | MICRO THERAPEUTICS, INC. | REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA | 09/28/2000 |
| K001966 | MICRO THERAPEUTICS, INC. | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND | 07/20/2000 |
| K024118 | MICRO THERAPEUTICS, INC. | ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 | 02/03/2003 |
| K202318 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Marathon Flow Directed Micro Catheter | 09/14/2020 |
| K152625 | MicroMedical Solutions, Inc. | MMS Guide Catheter | 03/09/2016 |
| K011646 | NEURO VASX, INC. | NEUROEDGE INFUSION CATHETER | 08/27/2001 |
| K033726 | PRECISION VASCULAR | PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER | 01/16/2004 |
| K020733 | PRECISION VASCULAR SYSTEMS, INC. | PVS 1500 SDS | 03/21/2002 |
| K032494 | PRECISION VASCULAR SYSTEMS, INC. | PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER | 09/05/2003 |
| K953133 | SCIMED LIFE SYSTEMS, INC. | SCIMED DISPATCH CORONARY INFUSION CATHETER | 02/23/1996 |
| K961294 | SCIMED LIFE SYSTEMS, INC. | SCIMED DISPATCH GOLD CORONARY CATHETER | 07/03/1996 |
| K123477 | SEQUENT MEDICAL, INC | VIA MICROCATHETER, VIA PLUS MICROCATHETER | 03/19/2013 |
| K213442 | Smartwise Sweden AB | Extroducer Infusion Catheter System | 06/10/2022 |
| K113773 | ST. JUDE MEDICAL | ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL | 01/18/2012 |
| K171665 | Suzhou Hengrui Disheng Medical Co.,Ltd. | Microcatheter and guide-wire system | 01/11/2018 |
| K212719 | Suzhou Hengrui Hongyuan Medical Co., Ltd | Micro Catheter and Guidewire System | 04/11/2022 |
| K965189 | TARGET THERAPEUTICS | SPINNAKER | 03/24/1997 |
| K082519 | TERUMO MEDICAL CORP. | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | 09/26/2008 |
| K033913 | TERUMO MEDICAL CORP. | PROGREAT | 03/11/2004 |
| K130569 | Translational Research Institute | ND NABIL DIB INFUSION CATHETER | 11/15/2013 |
| K193107 | TriSalus Life Sciences | TriSalus Infusion System | 12/03/2019 |
| K230957 | TriSalus Life Sciences | TriSalus TriNav« LV Infusion System | 05/02/2023 |
| K053310 | VASCON LLC | VASCON ROAMER MICROCATHETER | 07/03/2008 |
| K081147 | VASCULAR DESIGNS INC. | ISOFLOW INFUSION CATHETER | 05/29/2009 |
| K071468 | VASCULAR INSIGHTS LLC | CLARIVEIN CATHETER | 03/20/2008 |
| K153502 | VASCULAR INSIGHTS, LLC | ClariVein IC | 01/06/2016 |
| K222679 | VascuPatent Medical (Shenzhen) Co. Ltd. | Vericor Support Catheter | 11/07/2022 |
| K052738 | VEINRX INC. | INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 | 12/06/2005 |
| K073400 | VEINRX INC. | VARICATH PERIPHERAL INFUSION CATHETER | 12/20/2007 |
| K231148 | VVT Medical Ltd. | ScleroSafeÖ 150 mm, ScleroSafeÖ 350 mm | 06/20/2023 |
| K223139 | Wallaby Medical | Wallaby 017 Micro Catheter | 04/25/2023 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
