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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: DQX FDA class 2

    Wire, Guide, Catheter

    Cardiovascular

    View full classification →

    The Catheter Guide Wire is a flexible cardiovascular device used to navigate catheters through blood vessels to their intended target site during diagnostic or interventional 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 DQX and it is regulated under 21 CFR 870.1330 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    InQwire Amplatz Guide Wire
    FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
    Enroute 0.014'' Transcarotid Guidewire
    EmeryGlide™ (EG18008901)
    Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
    InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
    Solo Pace Fusion System (SOLOFUSE1)
    Lunderquist Extra Stiff Wire Guide
    SureAx-Guide™
    Amplatzer Guidewire
    Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)
    Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
    Medtronic Stedi Extra Support Guidewire
    SION blue PLUS
    Crossloop
    CROSSLEAD 0.018inch
    CROSSLEAD 0.014inch
    Prelude Small O.D. Introducer Guide Wire
    PTFE Guidewire
    R2P Radifocus Glidewire Advantage
    Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
    Arrow® Nitinol Wire
    Glidewire GT-R
    CROSSLEAD Tracker
    MINAMO blue; MINAMO viola
    FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
    PacePro Wire
    BNLE Hydrophilic Jacketed Peripheral Guidewire
    Mighty Wire Guide Wire
    Steerant™ Super Stiff Guidewire
    VASSALLO GT Crossing14
    VASSALLO GT 018 G12; VASSALLO GT 018 G30
    CROSSLEAD Penetration Peripheral Guide Wire
    TalWire
    Wattson temporary pacing guidewire (2250)
    BNLE Access Guidewire
    Vassallo GT 018 Hybrid
    ProTrack Pigtail Wire
    Mechanical Guidewire
    VASSALLO GT EXT
    Pre-Formed Blue
    EpiFaith CV
    SavvyWire
    ASAHI Gladius Mongo18 PV ES
    Stent Positioning Assistance System (SPAS)
    CROSSLEAD Peripheral Guide Wire
    VASSALLO GT 018 Floppy
    FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
    Medline Integrated Arterial Catheter
    Spartan Center Wire

    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.

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