FDA Product Code
FDA Product Code KRA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1210
510(k) Clearances — 177 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | 2026-09-21 | Traditional | PDF ↗ |
| K254051 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2026-09-11 | Traditional | PDF ↗ |
| K261610 | Verge Microcatheter | Instylla, Inc. | 2026-06-11 | Special | PDF ↗ |
| K260771 | TruSelect 2.6 Microcatheter | Boston Scientific Corporation | 2026-05-15 | Special | PDF ↗ |
| K250794 | InVera Infusion Device | Invera Medical | 2026-03-12 | Traditional | PDF ↗ |
| K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025-07-30 | Traditional | PDF ↗ |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Transit Scientific, LLC | 2023-11-29 | Traditional | PDF ↗ |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm | Ablative Solutions, Inc. | 2023-07-05 | Traditional | PDF ↗ |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mm | Vvt Medical , Ltd. | 2023-06-20 | Traditional | PDF ↗ |
| K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023-05-02 | Traditional | PDF ↗ |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 | Traditional | PDF ↗ |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister | Argon Medical Devices, Inc. | 2023-04-10 | Special | PDF ↗ |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | 2023-03-30 | Special | PDF ↗ |
| K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022-11-07 | Traditional | PDF ↗ |
| K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022-07-19 | Traditional | PDF ↗ |
| K213442 | Extroducer Infusion Catheter System | SmartWise Sweden AB | 2022-06-10 | Traditional | PDF ↗ |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | 2022-04-12 | Special | PDF ↗ |
| K212719 | Micro Catheter and Guidewire System | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022-04-11 | Traditional | PDF ↗ |
| K211110 | Agile Devices Angler Steerable, Deflectable Microcatheter | Agile Devices, Inc. | 2022-01-07 | Traditional | PDF ↗ |
| K210838 | PROWLER SELECT PLUS; PROWLER EX | Medos International SARL | 2021-08-25 | Special | PDF ↗ |
| K210339 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2021-08-02 | Traditional | PDF ↗ |
| K211525 | SwiftNINJA Steerable Microcatheter | Merit Medical Systems, Inc. | 2021-07-16 | Traditional | PDF ↗ |
| K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021-04-15 | Special | PDF ↗ |
| K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021-02-16 | Special | PDF ↗ |
| K202366 | MAGIC Infusion Catheter | Balt USA, LLC | 2021-01-29 | Traditional | PDF ↗ |
| K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-09-14 | Special | PDF ↗ |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | 2020-08-07 | Traditional | PDF ↗ |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020-08-06 | Special | PDF ↗ |
| K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020-07-28 | Special | PDF ↗ |
| K200582 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2020-06-25 | Traditional | PDF ↗ |
| K200744 | Instylla Microcatheter | Instylla, Inc. | 2020-04-21 | Special | PDF ↗ |
| K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | 2019-12-19 | Traditional | PDF ↗ |
| K193107 | TriSalus Infusion System | Trisalus Life Sciences | 2019-12-03 | Traditional | PDF ↗ |
| K191731 | Instylla Microcatheter | Instylla, Inc. | 2019-08-13 | Traditional | PDF ↗ |
| K182071 | Multi-Sideport Catheter Infusion Set | Cook Incorporated | 2019-04-25 | Traditional | PDF ↗ |
| K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018-11-08 | Traditional | PDF ↗ |
| K180275 | VAMP Optima closed blood sampling system | Edwards Lifesciences, LLC | 2018-10-24 | Traditional | PDF ↗ |
| K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018-04-05 | Traditional | PDF ↗ |
| K171665 | Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. | 2018-01-11 | Traditional | PDF ↗ |
| K170931 | CXI TriForce Peripheral Crossing Set | Cook Incorporated | 2017-11-13 | Special | PDF ↗ |
| K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | 2017-08-04 | Special | PDF ↗ |
| K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters | Boston Scientific Corporation | 2017-05-16 | Special | PDF ↗ |
| K161967 | FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm | Callisyn Biomedical, Inc. | 2017-01-27 | Traditional | PDF ↗ |
| K161962 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2016-11-28 | Traditional | PDF ↗ |
| K160884 | CXI Support Catheter | Cook Incorporated | 2016-11-22 | Special | PDF ↗ |
| K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016-11-04 | Traditional | PDF ↗ |
| K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016-08-18 | Traditional | PDF ↗ |
| K161801 | CrossCath Support Catheter | Cook Incorporated | 2016-07-29 | Special | PDF ↗ |
| K153501 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016-04-15 | Traditional | PDF ↗ |
| K152625 | MMS Guide Catheter | Micro Medical Solutions, Inc. | 2016-03-09 | Traditional | PDF ↗ |
| K153502 | ClariVein IC | Vascular Insights, LLC | 2016-01-06 | Special | PDF ↗ |
| K142259 | Direxion Torqueable Microcatheter | Boston Scientific Corp | 2014-09-10 | Special | PDF ↗ |
| K140329 | RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT | Boston Scientific | 2014-05-15 | Special | PDF ↗ |
| K140637 | PEREGRINE SYSTEM INFUSION CATHETER | Ablative Solutions, Inc. | 2014-03-26 | Traditional | PDF ↗ |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | Cook, Inc. | 2014-02-20 | Traditional | PDF ↗ |
| K130569 | ND NABIL DIB INFUSION CATHETER | Translational Research Institute | 2013-11-15 | Traditional | PDF ↗ |
| K132947 | DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS | Boston Scientific Corp | 2013-10-18 | Special | PDF ↗ |
| K123477 | VIA MICROCATHETER, VIA PLUS MICROCATHETER | Sequent Medical, Inc. | 2013-03-19 | Traditional | PDF ↗ |
| K122796 | CXI SUPPORT CATHETER | Cook, Inc. | 2012-10-11 | Special | PDF ↗ |
| K113289 | ORION MICRO CATHETER | Micro Therapeutics, Inc. | 2012-08-01 | Traditional | PDF ↗ |
| K113773 | ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL | St Jude Medical | 2012-01-18 | Traditional | PDF ↗ |
| K111490 | MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS | Ev3, Inc. | 2011-09-16 | Special | PDF ↗ |
| K111263 | CXI TRIFORCE | Cook Incorporated | 2011-07-25 | Traditional | PDF ↗ |
| K101450 | CANTATA MICROCATHETER | Cook, Inc. | 2010-12-30 | Special | PDF ↗ |
| K100892 | RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX | Boston Scientific Corp | 2010-04-12 | Special | PDF ↗ |
| K093750 | ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA | Ev3, Inc. | 2009-12-09 | Special | PDF ↗ |
| K093052 | CROSSCATH SUPPORT CATHTER | Cook, Inc. | 2009-12-08 | Traditional | PDF ↗ |
| K091559 | MARKSMANN CATHETER | Chestnut Medical Technologies, Inc. | 2009-09-18 | Traditional | PDF ↗ |
| K081147 | ISOFLOW INFUSION CATHETER | Vascular Designs, Inc. | 2009-05-29 | Traditional | PDF ↗ |
| K090870 | ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY | Micro Therapeutics, Inc. | 2009-05-01 | Special | PDF ↗ |
| K082613 | MERIT MICROCATHETER | Merit Medical Systems, Inc. | 2008-12-30 | Traditional | PDF ↗ |
| K082163 | FLOWMEDICA BENEPHIT INFUSION SYSTEMS | Flowmedica, Inc. | 2008-10-29 | Traditional | PDF ↗ |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Terumo Medical Corp. | 2008-09-26 | Traditional | PDF ↗ |
| K080737 | MIRAFLEX HIGH FLOW MICROCATHETER | Cook, Inc. | 2008-08-08 | Special | PDF ↗ |
| K053310 | VASCON ROAMER MICROCATHETER | Vascon, LLC | 2008-07-03 | Traditional | PDF ↗ |
| K073166 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | 2008-04-22 | Traditional | PDF ↗ |
| K071468 | CLARIVEIN CATHETER | Vascular Insights, LLC | 2008-03-20 | Abbreviated | PDF ↗ |
| K073400 | VARICATH PERIPHERAL INFUSION CATHETER | Veinrx, Inc. | 2007-12-20 | Special | PDF ↗ |
| K072724 | CXI SUPPORT CATHETER | Cook, Inc. | 2007-11-09 | Special | PDF ↗ |
| K070979 | PULL TAB SQUEEZE FLUSH | Icu Medical, Inc. | 2007-09-19 | Special | PDF ↗ |
| K070384 | ARGON CONTINUOUS FLUSH DEVICE | Argon Medical Devices, Inc. | 2007-03-29 | Traditional | PDF ↗ |
| K070279 | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 2007-03-14 | Special | PDF ↗ |
| K062752 | MERCATOR MICROSYRINGE II INFUSION CATHETER | Mercator Medsystems, Inc. | 2006-12-07 | Traditional | PDF ↗ |
| K060224 | MODIFICATION TO MIRA-FLEX 18 MICROCATHETER | Cook Incorporated | 2006-03-06 | Special | PDF ↗ |
| K051990 | ECHELON MICRO CATHETER | Micro Therapeutics, Inc. | 2006-01-04 | Traditional | PDF ↗ |
| K052841 | MIRA-FLEX 18 MICROCATHETER | Cook, Inc. | 2005-12-08 | Special | PDF ↗ |
| K052738 | INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 | Veinrx, Inc. | 2005-12-06 | Special | PDF ↗ |
| K043538 | HYPERTRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 2005-04-18 | Traditional | PDF ↗ |
| K050630 | PIVOT STEERABLE MICROCATHETER | Boston Scientific - Precision Vascular | 2005-03-22 | Special | PDF ↗ |
| K050205 | BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH | Flowmedica, Inc. | 2005-03-04 | Special | PDF ↗ |
| K042187 | ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 | Micro Therapeutics, Inc. | 2004-09-02 | Special | PDF ↗ |
| K033913 | PROGREAT | Terumo Medical Corp. | 2004-03-11 | Traditional | PDF ↗ |
| K040139 | ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER | Endobionics, Inc. | 2004-02-18 | Traditional | PDF ↗ |
| K034036 | MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 | Micro Therapeutics, Inc. | 2004-02-13 | Traditional | PDF ↗ |
| K033726 | PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER | Precision Vascular | 2004-01-16 | Special | PDF ↗ |
| K033569 | FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH | Flowmedica, Inc. | 2004-01-13 | Traditional | PDF ↗ |
| K032494 | PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER | Precision Vascular Systems, Inc. | 2003-09-05 | Special | PDF ↗ |
| K031992 | ECHELON MICRO CATHETER, MODEL 105-5091 | Micro Therapeutics, Inc. | 2003-08-07 | Special | PDF ↗ |
| K030688 | ECHELON MICRO CATHETER, MODEL 105-5092-150 | Micro Therapeutics, Inc. | 2003-03-28 | Special | PDF ↗ |
| K024122 | NAUTICA MICRO CATHETER, MODEL 105-5094-153 | Micro Therapeutics, Inc. | 2003-03-07 | Traditional | PDF ↗ |
Product code KRA · Class II · Cardiovascular. Data: openFDA.