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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: MOF FDA class 2

    Guide, Wire, Catheter, Neurovasculature

    Cardiovascular

    View full classification →

    The Neurovasculature Catheter Guide Wire is a cardiovascular device used to navigate and guide catheters through the neurovasculature (blood vessels of the brain and central nervous system) during interventional procedures such as the treatment of cerebral aneurysms or arteriovenous malformations. Classified as FDA Class 2 under 21 CFR 870.1330, it requires 510(k) premarket notification. The product code is MOF, and it is eligible for third-party 510(k) review.

    510(k) Clearances

    40 matches
    K Number
    Device Name
    Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire
    Zenith Micro Guidewire
    Willow 24 Guidewire
    DCwire Micro-guidewire
    Willow 18 Guidewire
    CHIKAI Nexus petit
    0.014” Willow Guidewire
    X-Wire Guidewire
    0.014” Willow Guidewire
    CHIKAI Nexus 014
    Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
    Synxess Neurovascular Guidewire
    Drivewire 24 Guidewire
    Aristotle 18 Guidewire; Aristotle 24 Guidewire
    SmartGUIDE deflectable hydrophilic guidewire
    Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
    Aristotle Colossus Guidewire
    RADIFOCUS Torque Device
    Columbus Guidewire
    Synchro SELECT Guidewire
    Traxcess 7 Mini Guidewire
    Traxcess 14 SELECT Guidewire
    ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
    Synchro2 Support Guidewire
    Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
    ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
    HYBRID Guidewire
    Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
    ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
    Traxcess 7 Mini XSoft Guidewire
    ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
    Traxcess .007 Mini Guidewire
    ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
    Traxcess Pro 14 Guidewire
    Viradius Neurowire
    ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
    TRAXCESS 14 GUIDEWIRE
    AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
    ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
    ASAHI CHIKAI NEUROVASCULAR GUIDE 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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