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

    ENCOR UNIPOLAR VS-1 LEADS

    K Number: K883070 · Decision Dec 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    4
    Review Days
    138

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    Basic Information

    Device Name
    ENCOR UNIPOLAR VS-1 LEADS
    K Number
    K883070
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cordis Leads, Inc.
    Date Received
    July 20, 1988
    Decision Date
    December 5, 1988
    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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    Other Clearances by Cordis Leads, Inc.

    K Number Device Name
    K873772 CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
    K882045 HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK
    K874366 ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201