ClearanceBrief
Panels › Cardiovascular › Product code KRA · Class 2

Catheter, Continuous Flush

Regulation 870.1210

5510(k)s in 12 months (177 all time)
41recalls in 12 months (137 all time)
135recalls that name a 510(k)
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Top companies in KRA

Company510(k)sRecalls
Boston Scientific Cork, Ltd.041
Merit Medical Systems, Inc.727
Cook Incorporated146
Boston Scientific118
Micro Therapeutics, Inc.172
Cordis Neurovascular, Inc.132
Ekos Corp.112
Edwards Lifesciences, LLC46
Angiodynamics, Inc.07
Becton Dickinson Medical Systems07
Decided510(k)Device and applicantCode
Sep 21, 2026K253509TriSalus TriNav Advance Infusion System
Trisalus Life Sciences
KRA
Sep 11, 2026K254051Extroducer Infusion Catheter System
SmartWise Sweden AB, SE
KRA
Jun 11, 2026K261610Verge™ Microcatheter
Instylla, Inc.
KRA
May 15, 2026K260771TruSelect™ 2.6 Microcatheter
Boston Scientific Corporation
KRA
Mar 12, 2026K250794InVera Infusion Device
Invera Medical, IE
KRA
Jul 30, 2025K243534Micro Catheter
Suzhou Zenith Vascular SciTech Limited, CN
KRA
Nov 29, 2023K231821XO 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
Transit Scientific, LLC
KRA
Jul 5, 2023K231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
Ablative Solutions, Inc.
KRA
Jun 20, 2023K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
Vvt Medical , Ltd., IL
KRA
May 2, 2023K230957TriSalus TriNav® LV Infusion System
Trisalus Life Sciences
KRA
Apr 25, 2023K223139Wallaby 017 Micro Catheter
Wallaby Medical
KRA
Apr 10, 2023K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire,
Argon Medical Devices, Inc.
KRA
Mar 30, 2023K230636Maestro Microcatheter
Merit Medical System, Inc.
KRA
Nov 7, 2022K222679Vericor Support Catheter
Vascupatent Medical (Shenzhen) Co., Ltd., CN
KRA
Jul 19, 2022K213435MAGIC Flow-Dependent Microcatheter
Balt USA, LLC
KRA
Jun 10, 2022K213442Extroducer Infusion Catheter System
SmartWise Sweden AB, SE
KRA
Apr 12, 2022K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
Medos International SARL, CH
KRA
Apr 11, 2022K212719Micro Catheter and Guidewire System
Suzhou Hengrui Hongyuan Medical Co., Ltd., CN
KRA
Jan 7, 2022K211110Agile Devices Angler Steerable, Deflectable Microcatheter
Agile Devices, Inc.
KRA
Aug 25, 2021K210838PROWLER SELECT PLUS; PROWLER EX
Medos International SARL, CH
KRA
Aug 2, 2021K210339Bullfrog Micro-Infusion Device
Mercator Medsystems, Inc.
KRA
Jul 16, 2021K211525SwiftNINJA Steerable Microcatheter
Merit Medical Systems, Inc.
KRA
Apr 15, 2021K210808Instylla Microcatheter 1.2
Instylla, Inc.
KRA
Feb 16, 2021K210114Rebar Micro Catheter
Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular
KRA
Jan 29, 2021K202366MAGIC Infusion Catheter
Balt USA, LLC
KRA
Sep 14, 2020K202318Marathon Flow Directed Micro Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
KRA
Aug 7, 2020K193082Fountain ValveTip Infusion Catheter
Merit Medical Systems, Inc.
KRA
Aug 6, 2020K201907ClariVein IC
Merit Medical Systems, Inc.
KRA
Jul 28, 2020K201792TRUSELECT Microcatheter
Boston Scientific Corporation
KRA
Jun 25, 2020K200582Bendit2.7 Steerable Microcatheter
Bend IT Technologies, Ltd., IL
KRA
Apr 21, 2020K200744Instylla Microcatheter
Instylla, Inc.
KRA
Dec 19, 2019K191305Hereaeus Poseidon Microcatheter
Heraeus Medical Components, LLC
KRA
Dec 3, 2019K193107TriSalus Infusion System
Trisalus Life Sciences
KRA
Aug 13, 2019K191731Instylla Microcatheter
Instylla, Inc.
KRA
Apr 25, 2019K182071Multi-Sideport Catheter Infusion Set
Cook Incorporated
KRA
Nov 8, 2018K181684VAMP Plus Venous/Arterial Blood Management Protection System
Edwards Lifesciences, LLC
KRA
Oct 24, 2018K180275VAMP Optima closed blood sampling system
Edwards Lifesciences, LLC
KRA
Apr 5, 2018K173586VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences, LLC
KRA
Jan 11, 2018K171665Microcatheter and guide-wire system
Suzhou Hengrui Disheng Medical Co., Ltd., CN
KRA
Nov 13, 2017K170931CXI TriForce Peripheral Crossing Set
Cook Incorporated
KRA
Aug 4, 2017K172081Maestro Microcatheter
Merit Medical Systems, Inc.
KRA
May 16, 2017K163701Direxion and Direxion HI-FLO Torqueable Microcatheters
Boston Scientific Corporation
KRA
Jan 27, 2017K161967FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm
Callisyn Biomedical, Inc.
KRA
Nov 28, 2016K161962VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences, LLC
KRA
Nov 22, 2016K160884CXI Support Catheter
Cook Incorporated
KRA
Nov 4, 2016K161921SwiftNINJA Microcatheter
Merit Medical Systems, Inc.
KRA
Aug 18, 2016K161402Bullfrog Micro-Infusion Device
Mercator Medsystems, Inc.
KRA
Jul 29, 2016K161801CrossCath Support Catheter
Cook Incorporated
KRA
Apr 15, 2016K153501Bullfrog Micro-Infusion Device
Mercator Medsystems, Inc.
KRA
Mar 9, 2016K152625MMS Guide Catheter
Micro Medical Solutions, Inc.
KRA

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