Atlas FDA

KRA

175 FDA 510(k) clearances · Product code

84 daysmedian time to decision
266 days90th percentile
175clearances measured

FDA profile

Official device name
Catheter, Continuous Flush
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1210
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 440 · 2022: 543 · 2023: 829 · 2024: 940 · 2025: 991 · 2026: 511
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Verge™ Microcatheter (K261610)Instylla, Inc.2026-06-11
TruSelect™ 2.6 Microcatheter (K260771)Boston Scientific Corporation2026-05-15
InVera Infusion Device (K250794)Invera Medical2026-03-12
Micro Catheter (K243534)Suzhou Zenith Vascular SciTech Limited2025-07-30
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,) (K231821)Transit Scientific, LLC2023-11-29
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm (K231279)Ablative Solutions, Inc.2023-07-05
ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (K231148)Vvt Medical , Ltd.2023-06-20
TriSalus TriNav® LV Infusion System (K230957)Trisalus Life Sciences2023-05-02
Wallaby 017 Micro Catheter (K223139)Wallaby Medical2023-04-25
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 (K223176)Argon Medical Devices, Inc.2023-04-10
Maestro Microcatheter (K230636)Merit Medical System, Inc.2023-03-30
Vericor Support Catheter (K222679)Vascupatent Medical (Shenzhen) Co., Ltd.2022-11-07
MAGIC Flow-Dependent Microcatheter (K213435)Balt USA, LLC2022-07-19
Extroducer Infusion Catheter System (K213442)SmartWise Sweden AB2022-06-10
PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter (K214025)Medos International SARL2022-04-12
Micro Catheter and Guidewire System (K212719)Suzhou Hengrui Hongyuan Medical Co., Ltd.2022-04-11
Agile Devices Angler Steerable, Deflectable Microcatheter (K211110)Agile Devices, Inc.2022-01-07
PROWLER SELECT PLUS; PROWLER EX (K210838)Medos International SARL2021-08-25
Bullfrog Micro-Infusion Device (K210339)Mercator Medsystems, Inc.2021-08-02
SwiftNINJA Steerable Microcatheter (K211525)Merit Medical Systems, Inc.2021-07-16
Instylla Microcatheter 1.2 (K210808)Instylla, Inc.2021-04-15
Rebar Micro Catheter (K210114)Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular2021-02-16
MAGIC Infusion Catheter (K202366)Balt USA, LLC2021-01-29
Marathon Flow Directed Micro Catheter (K202318)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-09-14
Fountain ValveTip Infusion Catheter (K193082)Merit Medical Systems, Inc.2020-08-07
ClariVein IC (K201907)Merit Medical Systems, Inc.2020-08-06
TRUSELECT Microcatheter (K201792)Boston Scientific Corporation2020-07-28
Bendit2.7 Steerable Microcatheter (K200582)Bend IT Technologies, Ltd.2020-06-25
Instylla Microcatheter (K200744)Instylla, Inc.2020-04-21
Hereaeus Poseidon Microcatheter (K191305)Heraeus Medical Components, LLC2019-12-19
TriSalus Infusion System (K193107)Trisalus Life Sciences2019-12-03
Instylla Microcatheter (K191731)Instylla, Inc.2019-08-13
Multi-Sideport Catheter Infusion Set (K182071)Cook Incorporated2019-04-25
VAMP Plus Venous/Arterial Blood Management Protection System (K181684)Edwards Lifesciences, LLC2018-11-08
VAMP Optima closed blood sampling system (K180275)Edwards Lifesciences, LLC2018-10-24
VAMP Venous/Arterial Blood Management Protection System (K173586)Edwards Lifesciences, LLC2018-04-05
Microcatheter and guide-wire system (K171665)Suzhou Hengrui Disheng Medical Co., Ltd.2018-01-11
CXI TriForce Peripheral Crossing Set (K170931)Cook Incorporated2017-11-13
Maestro Microcatheter (K172081)Merit Medical Systems, Inc.2017-08-04
Direxion and Direxion HI-FLO Torqueable Microcatheters (K163701)Boston Scientific Corporation2017-05-16
FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm (K161967)Callisyn Biomedical, Inc.2017-01-27
VAMP Venous/Arterial Blood Management Protection System (K161962)Edwards Lifesciences, LLC2016-11-28
CXI Support Catheter (K160884)Cook Incorporated2016-11-22
SwiftNINJA Microcatheter (K161921)Merit Medical Systems, Inc.2016-11-04
Bullfrog Micro-Infusion Device (K161402)Mercator Medsystems, Inc.2016-08-18
CrossCath Support Catheter (K161801)Cook Incorporated2016-07-29
Bullfrog Micro-Infusion Device (K153501)Mercator Medsystems, Inc.2016-04-15
MMS Guide Catheter (K152625)Micro Medical Solutions, Inc.2016-03-09
ClariVein IC (K153502)Vascular Insights, LLC2016-01-06
Direxion Torqueable Microcatheter (K142259)Boston Scientific Corp2014-09-10
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT (K140329)Boston Scientific2014-05-15
PEREGRINE SYSTEM INFUSION CATHETER (K140637)Ablative Solutions, Inc.2014-03-26
CANTATA(R) 2.9 MICROCATHETER (K131772)Cook, Inc.2014-02-20
ND NABIL DIB INFUSION CATHETER (K130569)Translational Research Institute2013-11-15
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS (K132947)Boston Scientific Corp2013-10-18
VIA MICROCATHETER, VIA PLUS MICROCATHETER (K123477)Sequent Medical, Inc.2013-03-19
CXI SUPPORT CATHETER (K122796)Cook, Inc.2012-10-11
ORION MICRO CATHETER (K113289)Micro Therapeutics, Inc.2012-08-01
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL (K113773)St Jude Medical2012-01-18
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS (K111490)Ev3, Inc.2011-09-16
CXI TRIFORCE (K111263)Cook Incorporated2011-07-25
CANTATA MICROCATHETER (K101450)Cook, Inc.2010-12-30
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX (K100892)Boston Scientific Corp2010-04-12
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA (K093750)Ev3, Inc.2009-12-09
CROSSCATH SUPPORT CATHTER (K093052)Cook, Inc.2009-12-08
MARKSMANN CATHETER (K091559)Chestnut Medical Technologies, Inc.2009-09-18
ISOFLOW INFUSION CATHETER (K081147)Vascular Designs, Inc.2009-05-29
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY (K090870)Micro Therapeutics, Inc.2009-05-01
MERIT MICROCATHETER (K082613)Merit Medical Systems, Inc.2008-12-30
FLOWMEDICA BENEPHIT INFUSION SYSTEMS (K082163)Flowmedica, Inc.2008-10-29
FINECROSS MG CORONARY MICRO-GUIDE CATHETER (K082519)Terumo Medical Corp.2008-09-26
MIRAFLEX HIGH FLOW MICROCATHETER (K080737)Cook, Inc.2008-08-08
VASCON ROAMER MICROCATHETER (K053310)Vascon, LLC2008-07-03
ENDOWAVE INFUSION SYSTEM (K073166)Ekos Corp.2008-04-22
CLARIVEIN CATHETER (K071468)Vascular Insights, LLC2008-03-20
VARICATH PERIPHERAL INFUSION CATHETER (K073400)Veinrx, Inc.2007-12-20
CXI SUPPORT CATHETER (K072724)Cook, Inc.2007-11-09
PULL TAB SQUEEZE FLUSH (K070979)Icu Medical, Inc.2007-09-19
ARGON CONTINUOUS FLUSH DEVICE (K070384)Argon Medical Devices, Inc.2007-03-29
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER (K070279)Cordis Neurovascular, Inc.2007-03-14
MERCATOR MICROSYRINGE II INFUSION CATHETER (K062752)Mercator Medsystems, Inc.2006-12-07
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER (K060224)Cook Incorporated2006-03-06
ECHELON MICRO CATHETER (K051990)Micro Therapeutics, Inc.2006-01-04
MIRA-FLEX 18 MICROCATHETER (K052841)Cook, Inc.2005-12-08
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 (K052738)Veinrx, Inc.2005-12-06
HYPERTRANSIT INFUSION CATHETER (K043538)Cordis Neurovascular, Inc.2005-04-18
PIVOT STEERABLE MICROCATHETER (K050630)Boston Scientific - Precision Vascular2005-03-22
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH (K050205)Flowmedica, Inc.2005-03-04
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 (K042187)Micro Therapeutics, Inc.2004-09-02
PROGREAT (K033913)Terumo Medical Corp.2004-03-11
ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER (K040139)Endobionics, Inc.2004-02-18
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 (K034036)Micro Therapeutics, Inc.2004-02-13
PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER (K033726)Precision Vascular2004-01-16
FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH (K033569)Flowmedica, Inc.2004-01-13
PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER (K032494)Precision Vascular Systems, Inc.2003-09-05
ECHELON MICRO CATHETER, MODEL 105-5091 (K031992)Micro Therapeutics, Inc.2003-08-07
ECHELON MICRO CATHETER, MODEL 105-5092-150 (K030688)Micro Therapeutics, Inc.2003-03-28
NAUTICA MICRO CATHETER, MODEL 105-5094-153 (K024122)Micro Therapeutics, Inc.2003-03-07
MAGIC INFUSION CATHETER (K023351)Advanced Interventional Technologies, LLC2003-02-20
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 (K024118)Micro Therapeutics, Inc.2003-02-03
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