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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: DQO FDA class 2

    Catheter, Intravascular, Diagnostic

    Cardiovascular

    View full classification →

    The Intravascular Diagnostic Catheter is a cardiovascular device inserted into blood vessels to measure hemodynamic parameters such as pressure, flow, or oxygen content during diagnostic procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQO and it is regulated under 21 CFR 870.1200 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
    pNOVUS 21 Microcatheter
    Impress Angiographic Catheter
    Zoom 6F Insert Catheters
    Soldier Microcatheter
    INFINITI™ Ambi Angiographic Catheter
    Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
    Drakon™ and Sequre® Microcatheters
    Dragonfly OpStar™ Imaging Catheter
    pNOVUS 21 Microcatheter
    NuCath Wedge Pressure Catheter
    Langston dual lumen catheter
    SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
    Progreat Lambda
    KDL Angiography Catheter
    Drakon and Sequre Microcatheters
    Drakon and Sequre Microcatheters
    Superpipe Angiographic Catheter
    ILUMIEN System with AptiVue Software version D.3
    Trevo Trak 21 Microcatheter
    Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1
    Bendit2.7 Steerable Microcatheter
    Impress Angiographic Catheter
    Polyethylene Catheter
    Arterial Pressure Monitoring Set/Tray
    Arterial Pressure Monitoring Set/Tray
    Polyethylene Catheter
    Royal Flush Plus High-Flow Catheter
    4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
    AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
    High-Flo Silver Polyethylene Catheter
    Surefire Spark Infusion System
    SeQure® NF and SeQure® Microcatheters
    Royal Flush Catheter
    Langston dual lumen catheter
    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
    Progreat
    White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
    Surefire Precision Infusion System
    Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
    Plato MICROCATH 27B Microcatheter
    Foresight Intracardiac Echocardiology (ICE) System
    Medline Waste Station
    NAMIC ClearaCIL Contrast Injection Lines
    Torcon NB Advantage Catheters
    DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
    Surefire Infusion System
    IntraNovo Microcatheter
    Foresight Intracardiac Echocardiography (ICE) System
    Impulse Angiographic Catheter, Expo Angiographic Catheter

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump