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

    MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT

    K Number: K910630 · Decision Apr 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    102
    Applicant Total
    468
    Review Days
    64

    Basic Information

    Device Name
    MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
    K Number
    K910630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    MEDTRONIC VASCULAR
    Date Received
    February 13, 1991
    Decision Date
    April 18, 1991
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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