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

    Tempo Temporary Pacing Lead

    K Number: K160260 · Decision Oct 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    267

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    Basic Information

    Device Name
    Tempo Temporary Pacing Lead
    K Number
    K160260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotrace Medical, Inc.
    Date Received
    February 1, 2016
    Decision Date
    October 25, 2016
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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