Catheter, Intravascular, Diagnostic
FDA product code DQO · 488 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1200
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-23 – 2026-06-26
DQO
2026-06-26
DQO
2026-05-28
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
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DQO
2026-03-25
Arterial Pressure Monitoring Set/Tray
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DQO
2025-07-17
DualView Catheter
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DQO
2025-01-31
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
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DQO
2024-11-12
pNOVUS 21 Microcatheter
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DQO
2024-05-22
Impress Angiographic Catheter
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DQO
2024-04-02
Zoom 6F Insert Catheters
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DQO
2024-02-23
Soldier Microcatheter
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DQO
2023-11-21
INFINITI™ Ambi Angiographic Catheter
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DQO
2023-08-08
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
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DQO
2023-06-01
Drakon™ and Sequre® Microcatheters
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DQO
2023-04-14
Dragonfly OpStar™ Imaging Catheter
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DQO
2022-11-28
pNOVUS 21 Microcatheter
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DQO
2022-10-06
NuCath Wedge Pressure Catheter
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DQO
2022-06-17
Langston dual lumen catheter
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DQO
2022-02-17
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
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DQO
2021-12-21
Progreat Lambda
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DQO
2020-12-11
Drakon and Sequre Microcatheters
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DQO
2020-10-23
Drakon and Sequre Microcatheters
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DQO
2020-07-29
Superpipe Angiographic Catheter
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DQO
2019-12-17
ILUMIEN System with AptiVue Software version D.3
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DQO
2019-11-22
Trevo Trak 21 Microcatheter
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DQO
2019-11-08
Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
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DQO
2019-08-22
Bendit2.7 Steerable Microcatheter
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DQO
2019-07-16
Impress Angiographic Catheter
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DQO
2019-03-22
Polyethylene Catheter
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DQO
2018-12-19
Arterial Pressure Monitoring Set/Tray
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DQO
2018-11-30
Arterial Pressure Monitoring Set/Tray
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DQO
2018-10-26
Polyethylene Catheter
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DQO
2018-10-05
Royal Flush Plus High-Flow Catheter
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DQO
2018-08-08
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
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DQO
2018-07-18
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
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DQO
2018-04-03
Surefire Spark Infusion System
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DQO
2018-04-03
High-Flo Silver Polyethylene Catheter
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DQO
2018-01-26
SeQure® NF and SeQure® Microcatheters
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DQO
2018-01-25
Royal Flush Catheter
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DQO
2017-11-17
Langston dual lumen catheter
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DQO
2017-11-15
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
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DQO
2017-07-21
Progreat
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DQO
2017-05-26
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
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DQO
2017-05-17
Surefire Precision Infusion System
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DQO
2017-04-28
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
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DQO
2017-04-18
Plato MICROCATH 27B Microcatheter
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DQO
2017-03-28
Foresight Intracardiac Echocardiology (ICE) System
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DQO
2017-01-19
Medline Waste Station
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DQO
2017-01-06
NAMIC ClearaCIL Contrast Injection Lines
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DQO
2016-10-27
Torcon NB Advantage Catheters
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DQO
2016-08-19
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
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DQO
2016-03-11
Surefire Infusion System
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DQO
2016-01-13
IntraNovo Microcatheter
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DQO
2013-10-11
MODIFIED CONCENTRIC MICROCATHETER
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DQO
2013-03-04
URSA ANGIOGRAPHIC CATHETER
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DQO
2012-12-14
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
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DQO
2012-09-14
IMAGER II ANGIOGRAPHIC CATHETER
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DQO
2012-08-17
MEDLINE HIGH PRESSURE INJECTION TUBING
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DQO
2012-08-02
HEADWAY DUO MICROCATHETER
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DQO
2012-07-30
PLATO MICROCATH 27 MICROCATHETER
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DQO
2012-07-17
NMI MICROCATHETER
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DQO
2012-07-16
HEARTRAIL III GUIDING CATHETER
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DQO
2012-07-11
MONGOOSE ANGIOGRAPHIC CATHETER
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DQO
2012-06-14
SUREFIRE HI-FLOW MICROCATHETER
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DQO
2012-05-21
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
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DQO
2012-03-30
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
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DQO
2012-03-29
IMAGER II ANGIOGRAPHIC CATHETERS
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DQO
2012-03-09
MODIFIED CONCENTIRC MICROCATHETER
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DQO
2012-02-23
SUREFIRE GUIDE SHEATH
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DQO
2012-01-05
NMI 2.8 MICROCATHETER
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DQO
2011-09-09
BIOTEQ ANGIOGRAPHIC CATHETER
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DQO
2011-08-19
MICROCATHETER
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DQO
2011-07-06
MODIFIED CONCENTRIC MICROCATHETER
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DQO
2011-07-01
MERIT MARQUIS FLOW SWITCH
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DQO
2011-06-24
SUREFIRE INFUSION CATHETER SYSTEM
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DQO
2011-02-11
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
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DQO
2010-07-19
COHEN CROSSOVER CATHETER
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DQO
2010-07-01
THERMODILUTION CATHETER
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DQO
2010-06-02
VIEWFLEX PLUS ICE CATHETER
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DQO
2010-02-12
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
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DQO
2010-01-29
URSA ANGIOGRAPHIC CATHETER
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DQO
2010-01-13
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
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DQO
2010-01-05
THERMODILUTION CATHETER
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DQO
2009-11-20
MICRUS MICROCATHETER, MODEL COURIER 270
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DQO
2009-10-16
GUIDED MEASUREMENT CATHETER (GMC)
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DQO
2009-09-11
HEARTRAIL III GUIDING CATHETER
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DQO
2009-07-30
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
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DQO
2009-05-06
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
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DQO
2009-02-19
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
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DQO
2009-02-06
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
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DQO
2009-01-28
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
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DQO
2008-09-24
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
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DQO
2008-04-17
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
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DQO
2008-02-01
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
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DQO
2007-12-18
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
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DQO
2007-10-05
MICRUS COURIER ENZO MICROCATHETER 0.0190
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DQO
2007-09-06
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
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DQO
2007-05-24
MICRUS COURIER ENZO MICROCATHETER 0.017
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DQO
2007-04-16
DYE MANAGEMENT SYSTEM
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DQO
2007-03-20
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER
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DQO
2007-01-18
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
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DQO
2007-01-05
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905
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