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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: PDU FDA class 2

    Catheter For Crossing Total Occlusions

    Cardiovascular

    View full classification →

    The Catheter for Crossing Total Occlusions is a cardiovascular device used to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions, including subchronic and chronic total occlusions in peripheral or coronary vessels. It falls under the Cardiovascular medical specialty and is classified as a Class 2 device under regulation 870.1250, requiring 510(k) premarket notification. These catheters are used in interventional cardiology and vascular procedures to enable revascularization of completely blocked arteries. It is not an implant and is not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    LimFlow ARC
    PowerWire Radiofrequency Guidewire Kit
    SoundBite® Crossing System XS Peripheral
    Tigereye ST CTO-Crossing Catheter
    Tunnel Crossing Catheter
    LimFlow ARC
    DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
    GoBack Crossing Catheter
    Tigereye CTO-Crossing Catheter
    Crosser iQ CTO Recanalization System
    DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
    SoundBite Crossing System - Peripheral (14P)
    Tigereye CTO-Crossing Catheter
    SoundBite Console, SoundBite Active Wire 18
    XableCath Crossing Catheter
    RA-308 Excimer Laser System, Excimer Laser Catheter
    Pioneer Plus Catheter
    CROSSER CTO Recanalization Catheter
    ELITECROSS Support Catheter
    OUTBACK Elite Re-Entry Catheter
    MICRO GUIDE CATHETER ELITE
    OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
    TRUEPATH CTO DEVICE
    OFFROAD RE-ENTRY CATHETER SYSTEM
    OCELOT PIXL CATHETER
    OCELOT CATHETER
    OCELOT SYSTEM
    BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
    KITTYCAT CATHETER, KITTYCAT 2 CATHETER
    WILDCAT CATHETER
    CROSSER RECANALIZATION SYSTEM
    WILDCAT CATHETER
    RVT CTO DEVICE
    POWERWIRE RADIOFREQUENCY GUIDEWIRE
    PIONEER PLUS CATHETER, MODEL PLUS 120
    THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
    MODIFICATION TO THE CROSSER SYSTEM
    OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
    MICRO GUIDE CATHETER XP
    PIONEER PLUS CATHETER
    THE CROSSER SYSTEM
    PIONEER CATHETER
    CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
    8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
    CLIRPATH TURBO PERIPHERAL CATHETERS
    RF TUNNELER WIRE
    CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
    CLIRPATH TURBO EXCIMER LASER CATHETERS
    2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
    SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]

    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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