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510(k) Data Aggregation

    K Number
    K021608
    Device Name
    SMITHWICK CAROTID SHUNT
    Manufacturer
    IMPLANTABLE DEVICES
    Date Cleared
    2002-10-22

    (159 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Carotid Shunt is intended to be used in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Smithwick Carotid Shunt. It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

    Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot extract the requested information from the provided text. The letter only confirms that the device can be legally marketed following FDA review, but it does not detail the specific data or studies that led to that determination.

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