BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    PERMANENT ENDOCARD. UNIPOLAR TINED LEAD

    K Number: K812905 · Decision Feb 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    9
    Review Days
    108

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    Basic Information

    Device Name
    PERMANENT ENDOCARD. UNIPOLAR TINED LEAD
    K Number
    K812905
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Diag Corp.
    Date Received
    October 19, 1981
    Decision Date
    February 4, 1982
    Product Code
    DTB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode

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