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510(k) Data Aggregation

    K Number
    K101839
    Device Name
    KANEKA PHARMA AMERICA XPRESS-WAY RX
    Manufacturer
    KANEKA PHARMA AMERICA LLC
    Date Cleared
    2010-10-22

    (113 days)

    Product Code
    QEZ,DXE,OEZ
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KANEKA PHARMA AMERICA XPRESS-WAY RX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are FDA 510(k) clearance letters for the Xpress-Way RX embolectomy catheter. These letters confirm the device's substantial equivalence to predicate devices but do not contain information about acceptance criteria, study designs, performance data, or ground truth establishment.

    Therefore, I cannot provide the requested information based solely on the given text. To describe the acceptance criteria and the study that proves the device meets them, I would need to access the actual 510(k) submission (K101839) or related performance studies, which are not included in these documents.

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