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510(k) Data Aggregation

    K Number
    K121301
    Device Name
    XPRESSWAY RX CATHETER (6F LD-VERISON)
    Manufacturer
    KANEKA PHARMA AMERICA LLC
    Date Cleared
    2012-07-30

    (90 days)

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

    XPRESSWAY RX CATHETER (6F LD-VERISON)

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

    The Xpress-Way™ RX Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

    The Xpress-Way™ RX Extraction Catheter is not intended for use in the cerebral vasculature.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the XpressWay™ RX Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance, or human studies for AI devices. It's a regulatory approval notice for a physical medical device (catheter), not an AI algorithm.

    Therefore, I cannot fulfill your request using the provided input because the required information is not present in this document. The document describes the regulatory process for a physical medical device, not the validation of an AI algorithm.

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