KRA

Bullfrog Micro-Infusion Device

Advisory panel: Cardiovascular
Total cleared: 173

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KRA

1–100 of 173

K250794 — InVera Infusion Device Invera Medical · 2026-03-12
K243534 — Micro Catheter Suzhou Zenith Vascular SciTech Limited · 2025-07-30
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
K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm Ablative Solutions, Inc. · 2023-07-05
K231148 — ScleroSafe 150 mm, ScleroSafe 350 mm Vvt Medical , Ltd. · 2023-06-20
K230957 — TriSalus TriNav® LV Infusion System Trisalus Life Sciences · 2023-05-02
K223139 — Wallaby 017 Micro Catheter Wallaby Medical · 2023-04-25
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
K230636 — Maestro Microcatheter Merit Medical System, Inc. · 2023-03-30
K222679 — Vericor Support Catheter Vascupatent Medical (Shenzhen) Co., Ltd. · 2022-11-07
K213435 — MAGIC Flow-Dependent Microcatheter Balt USA, LLC · 2022-07-19
K213442 — Extroducer Infusion Catheter System SmartWise Sweden AB · 2022-06-10
K214025 — PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter Medos International SARL · 2022-04-12
K212719 — Micro Catheter and Guidewire System Suzhou Hengrui Hongyuan Medical Co., Ltd. · 2022-04-11
K211110 — Agile Devices Angler Steerable, Deflectable Microcatheter Agile Devices, Inc. · 2022-01-07
K210838 — PROWLER SELECT PLUS; PROWLER EX Medos International SARL · 2021-08-25
K210339 — Bullfrog Micro-Infusion Device Mercator Medsystems, Inc. · 2021-08-02
K211525 — SwiftNINJA Steerable Microcatheter Merit Medical Systems, Inc. · 2021-07-16
K210808 — Instylla Microcatheter 1.2 Instylla, Inc. · 2021-04-15
K210114 — Rebar Micro Catheter Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021-02-16
K202366 — MAGIC Infusion Catheter Balt USA, LLC · 2021-01-29
K202318 — Marathon Flow Directed Micro Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020-09-14
K193082 — Fountain ValveTip Infusion Catheter Merit Medical Systems, Inc. · 2020-08-07
K201907 — ClariVein IC Merit Medical Systems, Inc. · 2020-08-06
K201792 — TRUSELECT Microcatheter Boston Scientific Corporation · 2020-07-28
K200582 — Bendit2.7 Steerable Microcatheter Bend IT Technologies, Ltd. · 2020-06-25
K200744 — Instylla Microcatheter Instylla, Inc. · 2020-04-21
K191305 — Hereaeus Poseidon Microcatheter Heraeus Medical Components, LLC · 2019-12-19
K193107 — TriSalus Infusion System Trisalus Life Sciences · 2019-12-03
K191731 — Instylla Microcatheter Instylla, Inc. · 2019-08-13
K182071 — Multi-Sideport Catheter Infusion Set Cook Incorporated · 2019-04-25
K181684 — VAMP Plus Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC · 2018-11-08
K180275 — VAMP Optima closed blood sampling system Edwards Lifesciences, LLC · 2018-10-24
K173586 — VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC · 2018-04-05
K171665 — Microcatheter and guide-wire system Suzhou Hengrui Disheng Medical Co., Ltd. · 2018-01-11
K170931 — CXI TriForce Peripheral Crossing Set Cook Incorporated · 2017-11-13
K172081 — Maestro Microcatheter Merit Medical Systems, Inc. · 2017-08-04
K163701 — Direxion and Direxion HI-FLO Torqueable Microcatheters Boston Scientific Corporation · 2017-05-16
K161967 — FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm Callisyn Biomedical, Inc. · 2017-01-27
K161962 — VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC · 2016-11-28
K160884 — CXI Support Catheter Cook Incorporated · 2016-11-22
K161921 — SwiftNINJA Microcatheter Merit Medical Systems, Inc. · 2016-11-04
K161402 — Bullfrog Micro-Infusion Device Mercator Medsystems, Inc. · 2016-08-18
K161801 — CrossCath Support Catheter Cook Incorporated · 2016-07-29
K153501 — Bullfrog Micro-Infusion Device Mercator Medsystems, Inc. · 2016-04-15
K152625 — MMS Guide Catheter Micro Medical Solutions, Inc. · 2016-03-09
K153502 — ClariVein IC Vascular Insights, LLC · 2016-01-06
K142259 — Direxion Torqueable Microcatheter Boston Scientific Corp · 2014-09-10
K140329 — RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT Boston Scientific · 2014-05-15
K140637 — PEREGRINE SYSTEM INFUSION CATHETER Ablative Solutions, Inc. · 2014-03-26
K131772 — CANTATA(R) 2.9 MICROCATHETER Cook, Inc. · 2014-02-20
K130569 — ND NABIL DIB INFUSION CATHETER Translational Research Institute · 2013-11-15
K132947 — DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS Boston Scientific Corp · 2013-10-18
K123477 — VIA MICROCATHETER, VIA PLUS MICROCATHETER Sequent Medical, Inc. · 2013-03-19
K122796 — CXI SUPPORT CATHETER Cook, Inc. · 2012-10-11
K113289 — ORION MICRO CATHETER Micro Therapeutics, Inc. · 2012-08-01
K113773 — ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL St Jude Medical · 2012-01-18
K111490 — MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS Ev3, Inc. · 2011-09-16
K111263 — CXI TRIFORCE Cook Incorporated · 2011-07-25
K101450 — CANTATA MICROCATHETER Cook, Inc. · 2010-12-30
K100892 — RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX Boston Scientific Corp · 2010-04-12
K093750 — ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA Ev3, Inc. · 2009-12-09
K093052 — CROSSCATH SUPPORT CATHTER Cook, Inc. · 2009-12-08
K091559 — MARKSMANN CATHETER Chestnut Medical Technologies, Inc. · 2009-09-18
K081147 — ISOFLOW INFUSION CATHETER Vascular Designs, Inc. · 2009-05-29
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
K082613 — MERIT MICROCATHETER Merit Medical Systems, Inc. · 2008-12-30
K082163 — FLOWMEDICA BENEPHIT INFUSION SYSTEMS Flowmedica, Inc. · 2008-10-29
K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER Terumo Medical Corp. · 2008-09-26
K080737 — MIRAFLEX HIGH FLOW MICROCATHETER Cook, Inc. · 2008-08-08
K053310 — VASCON ROAMER MICROCATHETER Vascon, LLC · 2008-07-03
K073166 — ENDOWAVE INFUSION SYSTEM Ekos Corp. · 2008-04-22
K071468 — CLARIVEIN CATHETER Vascular Insights, LLC · 2008-03-20
K073400 — VARICATH PERIPHERAL INFUSION CATHETER Veinrx, Inc. · 2007-12-20
K072724 — CXI SUPPORT CATHETER Cook, Inc. · 2007-11-09
K070979 — PULL TAB SQUEEZE FLUSH Icu Medical, Inc. · 2007-09-19
K070384 — ARGON CONTINUOUS FLUSH DEVICE Argon Medical Devices, Inc. · 2007-03-29
K070279 — MODIFICATION TO HYPERTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. · 2007-03-14
K062752 — MERCATOR MICROSYRINGE II INFUSION CATHETER Mercator Medsystems, Inc. · 2006-12-07
K060224 — MODIFICATION TO MIRA-FLEX 18 MICROCATHETER Cook Incorporated · 2006-03-06
K051990 — ECHELON MICRO CATHETER Micro Therapeutics, Inc. · 2006-01-04
K052841 — MIRA-FLEX 18 MICROCATHETER Cook, Inc. · 2005-12-08
K052738 — INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 Veinrx, Inc. · 2005-12-06
K043538 — HYPERTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. · 2005-04-18
K050630 — PIVOT STEERABLE MICROCATHETER Boston Scientific - Precision Vascular · 2005-03-22
K050205 — BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH Flowmedica, Inc. · 2005-03-04
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
K033913 — PROGREAT Terumo Medical Corp. · 2004-03-11
K040139 — ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER Endobionics, Inc. · 2004-02-18
K034036 — MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 Micro Therapeutics, Inc. · 2004-02-13
K033726 — PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER Precision Vascular · 2004-01-16
K033569 — FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH Flowmedica, Inc. · 2004-01-13
K032494 — PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER Precision Vascular Systems, Inc. · 2003-09-05
K031992 — ECHELON MICRO CATHETER, MODEL 105-5091 Micro Therapeutics, Inc. · 2003-08-07
K030688 — ECHELON MICRO CATHETER, MODEL 105-5092-150 Micro Therapeutics, Inc. · 2003-03-28
K024122 — NAUTICA MICRO CATHETER, MODEL 105-5094-153 Micro Therapeutics, Inc. · 2003-03-07
K023351 — MAGIC INFUSION CATHETER Advanced Interventional Technologies, LLC · 2003-02-20
K024118 — ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 Micro Therapeutics, Inc. · 2003-02-03
K021591 — PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc. · 2002-05-22
K020680 — PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc. · 2002-03-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.