BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS

    K Number: K043246 · Decision Feb 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    148
    Applicant Total
    566
    Review Days
    71

    Basic Information

    Device Name
    BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
    K Number
    K043246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. BARD, INC.
    Date Received
    November 23, 2004
    Decision Date
    February 2, 2005
    Product Code
    KXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KXK Source, Brachytherapy, Radionuclide

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