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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: DXC FDA class 2

    Clamp, Vascular

    Cardiovascular

    View full classification →

    The Vascular Clamp is a cardiovascular surgical instrument used to temporarily occlude blood flow through a vessel segment during vascular repair, anastomosis, or other surgical interventions, allowing the surgeon to operate in a bloodless field. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXC and it is regulated under 21 CFR 870.4450 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
    Arc Adjustable Radial Cuff Compression Device
    Life Saving Tourniquet
    Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
    Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
    Radial Compression Device
    PICOCLAMP
    Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
    VIOLA
    Radial Artery Compression Tourniquets
    GEM Biover Microvascular Clamps
    TR BAND Radial Compression Device
    SiteSeal SV
    MI DeTACH
    V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
    VIOLA
    VASOBand Vascular Compression Device
    Patent Hemostasis Band (PH Band)
    SiteSeal Femoral Compression Device
    Sunmed Disposable Angio-Closure Pads
    Site Seal SV
    VASOBand Vascular Compression Device
    PreludeSYNC DISTAL Radial Compression System
    ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
    ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
    IntraClude Intra-Aortic Occlusion Device
    PreludeSYNC Radial Compression Device
    TRAcelet Compression Device
    Vein Clamps, Artery Clamps
    VasoStat Hemostasis Device
    TR BAND Radial Compression Device
    Zephyr Vascular Compression Device
    Bookwalter Gordon Adjustable Compression Element
    iTClamp50
    CROC
    RADAR VASCULAR COMPRESSION DEVICE
    Vasc Band hemostat
    ITCLAMP 50
    SYVEK RADIAL BAND
    ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
    ITCLAMP 50
    COSEAL
    EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
    CARDIO VISION MICS AORTIC CLAMPS
    SAM JUNCTIONAL TOURNIQUET
    HEARTSTRING III PROXIMAL SEAL SYSTEM
    VASOSTAT HEMOSTASIS DEVICE
    ITCLAMP 50
    VASCULAR CLAMPS
    COMBAT READY CLAMP

    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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