LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCPHERSON ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Ask a Question
    K Number
    K062474
    Device Name
    SMITHWICK CAROTID SHUNT
    Manufacturer
    MCPHERSON ENTERPRISES, INC.
    Date Cleared
    2006-11-09

    (77 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCPHERSON ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used during carotid endarterectomies as a temporary conduit, to allow for blood flow between the common and internal carotid arteries.
    Device Description
    A tapered shunt used to divert blood flow from the common carotid artery to the internal carotid during carotid endarterectomy.
    Ask a Question

    Page 1 of 1