Atlas FDA

DQO

501 FDA 510(k) clearances · Product code

88 daysmedian time to decision
259 days90th percentile
501clearances measured

FDA profile

Official device name
Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 338 · 2022: 379 · 2023: 391 · 2024: 511 · 2025: 665 · 2026: 521
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Arterial Pressure Monitoring Set/Tray (K261455)Spectrum Vascular2026-06-26
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N (K252702)Bioptimal International Pte. , Ltd.2026-05-28
Arterial Pressure Monitoring Set/Tray (K254278)Spectrum Vascular2026-03-25
DualView Catheter (K250751)Terumo Corporation2025-07-17
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966)Gentuity, LLC2025-01-31
pNOVUS 21 Microcatheter (K242420)Phenox, Ltd.2024-11-12
Impress Angiographic Catheter (K233268)Merit Medical Systems, Inc.2024-05-22
Zoom 6F Insert Catheters (K233975)Imperative Care, Inc.2024-04-02
Soldier Microcatheter (K232536)Embolx, Inc.2024-02-23
INFINITI™ Ambi Angiographic Catheter (K232573)Cordis US Corp2023-11-21
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K230620)Gentuity, LLC2023-08-08
Drakon™ and Sequre® Microcatheters (K231293)Accurate Medical Therapeutics2023-06-01
Dragonfly OpStar™ Imaging Catheter (K230411)ABBOTT MEDICAL2023-04-14
pNOVUS 21 Microcatheter (K221279)Phenox, Ltd.2022-11-28
NuCath Wedge Pressure Catheter (K213666)Pfm Medical, Inc.2022-10-06
Langston dual lumen catheter (K221470)Vascular Solutions, LLC2022-06-17
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands (K212977)Cordis Corporation2022-02-17
Progreat Lambda (K211078)Terumo Clinical Supply Co., Ltd.2021-12-21
Drakon and Sequre Microcatheters (K203487)Accurate Medical Therapeutics, Ltd.2020-12-11
Drakon and Sequre Microcatheters (K202797)Accurate Medical Therapeutics, Ltd.2020-10-23
Superpipe Angiographic Catheter (K193647)Suzhou Hengrui Disheng Medical Co., Ltd.2020-07-29
ILUMIEN System with AptiVue Software version D.3 (K192267)ABBOTT MEDICAL2019-12-17
Trevo Trak 21 Microcatheter (K192122)Stryker2019-11-22
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019)ABBOTT MEDICAL2019-11-08
Bendit2.7 Steerable Microcatheter (K190126)Bend IT Technologies, Ltd.2019-08-22
Impress Angiographic Catheter (K191608)Merit Medical Systems, Inc.2019-07-16
Polyethylene Catheter (K181722)Cook Incorporated2019-03-22
Arterial Pressure Monitoring Set/Tray (K180846)Cook Incorporated2018-12-19
Arterial Pressure Monitoring Set/Tray (K180792)Cook Incorporated2018-11-30
Polyethylene Catheter (K180286)Cook Incorporated2018-10-26
Royal Flush Plus High-Flow Catheter (K180054)Cook Incorporated2018-10-05
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters (K181836)Cordis, A Cardinal Health Company2018-08-08
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters (K173762)AngioDynamics, Inc.2018-07-18
High-Flo Silver Polyethylene Catheter (K172635)Cook Incorporated2018-04-03
Surefire Spark Infusion System (K180677)Surefire Medical, Inc.2018-04-03
SeQure® NF and SeQure® Microcatheters (K173430)Accurate Medical Therapeutics, Ltd.2018-01-26
Royal Flush Catheter (K171264)Cook Incorporated2018-01-25
Langston dual lumen catheter (K170544)Vascular Solutions, Inc.2017-11-17
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter (K173289)Cook Incorporated2017-11-15
Progreat (K170223)Ashitaka Factory of Terumo Corporation2017-07-21
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448)Cook Incorporated2017-05-26
Surefire Precision Infusion System (K171355)Surefire Medical, Inc.2017-05-17
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters (K161596)AngioDynamics, Inc.2017-04-28
Plato MICROCATH 27B Microcatheter (K170406)Scientia Vascular, LLC2017-04-18
Foresight Intracardiac Echocardiology (ICE) System (K162789)Conavi Medical, Inc.2017-03-28
Medline Waste Station (K160660)Medline Industries, Inc.2017-01-19
NAMIC ClearaCIL Contrast Injection Lines (K163141)AngioDynamics, Inc.2017-01-06
Torcon NB Advantage Catheters (K161822)Cook Incorporated2016-10-27
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak (K161287)Medtronic Vascular2016-08-19
Surefire Infusion System (K160662)Surefire Medical, Inc.2016-03-11
IntraNovo Microcatheter (K153125)Texasmedical Technologies, Inc.2016-01-13
Foresight Intracardiac Echocardiography (ICE) System (K151126)Colibri Technologies, Inc.2015-12-18
Impulse Angiographic Catheter, Expo Angiographic Catheter (K152605)Boston Scientific Corporation2015-10-29
Radifocus Optitorque Angiographic Catheter (K150232)Ashitaka Factory of Terumo Corp.2015-10-19
AngioDynamics Mariner Angiographic Catheters (K151724)AngioDynamics, Inc.2015-10-14
Plato MICROCATH 27B Microcatheter (K143398)Scientia Vascular, LLC2015-06-26
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters (K143604)Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S2015-06-25
IntraNovo 25 Microcatheter (K142817)Texasmedical Technologies, Inc.2015-04-23
SUMMED HIGH PRESSURE LINE (K140356)Sunny Medical Device (Shenzhen) Co., Ltd.2015-03-20
Surefire Infusion System 021 (K143588)Surefire Medical, Inc.2015-01-12
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (K133130)Cook, Inc.2015-01-09
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER (K141453)Lightlab Imaging, Inc.2014-09-19
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER (K141769)Lightlab Imaging, Inc.2014-08-18
PRESSURE CONNECTING TUBE (K131770)Shenzhen Ant Hi-Tech Industrial Co., Ltd.2014-02-26
MODIFIED CONCENTRIC MICROCATHETER (K131437)Concentric Medical, Inc.2013-10-11
URSA ANGIOGRAPHIC CATHETER (K123818)Curative Medical Technology, Inc.2013-03-04
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) (K122937)Cook, Inc.2012-12-14
IMAGER II ANGIOGRAPHIC CATHETER (K121694)Boston Scientific Corp2012-09-14
MEDLINE HIGH PRESSURE INJECTION TUBING (K120008)Medline Industries, Inc.2012-08-17
HEADWAY DUO MICROCATHETER (K120917)MicroVention, Inc.2012-08-02
PLATO MICROCATH 27 MICROCATHETER (K121734)Scientia Vascular, LLC2012-07-30
NMI MICROCATHETER (K121954)Navilyst Medical, Inc.2012-07-17
HEARTRAIL III GUIDING CATHETER (K113335)Terumo Corporation2012-07-16
MONGOOSE ANGIOGRAPHIC CATHETER (K113819)Pediacath, Inc.2012-07-11
SUREFIRE HI-FLOW MICROCATHETER (K121677)Surefire Medical, Inc.2012-06-14
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER (K120495)Boston Scientific Corp2012-05-21
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS (K112452)AngioDynamics, Inc.2012-03-30
IMAGER II ANGIOGRAPHIC CATHETERS (K120893)Boston Scientific Corp2012-03-29
MODIFIED CONCENTIRC MICROCATHETER (K113260)Concentric Medical, Inc.2012-03-09
SUREFIRE GUIDE SHEATH (K113737)Surefire Medical, Inc.2012-02-23
NMI 2.8 MICROCATHETER (K113638)Navilyst Medical, Inc.2012-01-05
BIOTEQ ANGIOGRAPHIC CATHETER (K102633)Bioteque Corp.2011-09-09
MICROCATHETER (K112124)Navilyst Medical, Inc.2011-08-19
MODIFIED CONCENTRIC MICROCATHETER (K111619)Concentric Medical, Inc.2011-07-06
MERIT MARQUIS FLOW SWITCH (K110643)Merit Medical Systems, Inc.2011-07-01
SUREFIRE INFUSION CATHETER SYSTEM (K110459)Surefire Medical, Inc.2011-06-24
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER (K110103)Edwards Lifesciences, LLC2011-02-11
COHEN CROSSOVER CATHETER (K101625)Vascular Solutions, Inc.2010-07-19
THERMODILUTION CATHETER (K101669)Biosensors Intl. Pte. , Ltd.2010-07-01
VIEWFLEX PLUS ICE CATHETER (K101239)St Jude Medical2010-06-02
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING (K093004)Merit Medical Systems, Inc.2010-02-12
URSA ANGIOGRAPHIC CATHETER (K090427)Curative Medical Technology, Inc.2010-01-29
ANGIOGRAPHIC CATHETER, MODEL ANGIOS (K092118)Oscor, Inc.2010-01-13
THERMODILUTION CATHETER (K083384)Biosensors Intl. Pte. , Ltd.2010-01-05
MICRUS MICROCATHETER, MODEL COURIER 270 (K092702)Micrus Endovascular Corporation2009-11-20
GUIDED MEASUREMENT CATHETER (GMC) (K091780)Mediguide, Ltd.2009-10-16
HEARTRAIL III GUIDING CATHETER (K092372)Terumo Corp.2009-09-11
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 (K091961)Concentric Medical, Inc.2009-07-30
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 (K083922)Micrus Endovascular Corporation2009-05-06
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM (K090276)Siemens Medical Solutions USA, Inc.2009-02-19
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