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510(k) Data Aggregation

    K Number
    K061484
    Device Name
    MODIFICATION TO: SMITHWICK CAROTID SHUNT
    Manufacturer
    MCPHERSON ENTERPRISES, INC.
    Date Cleared
    2006-12-07

    (191 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO: SMITHWICK CAROTID SHUNT

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

    The Smithwick Carotid Shunt intended use is for a carotid endanterectomy procedure. The Doppler crystal built into the shunt provides for Audible verification of blood flow during carotid endarterestomy.

    Device Description

    Smithwick Doppler and Non-Doppler Carotid Shunt

    AI/ML Overview

    This document is a letter from the FDA regarding the 510(k) premarket notification for the "Smithwick Carotid Shunt," and it does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing predicate devices, rather than detailed performance study results.

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