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

    MODEL 1148T TRANSVENOUS, SCREW-IN LEAD

    K Number: K925347 · Decision Jun 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    7
    Review Days
    231

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    Basic Information

    Device Name
    MODEL 1148T TRANSVENOUS, SCREW-IN LEAD
    K Number
    K925347
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens-Pacesetter, Inc.
    Date Received
    October 22, 1992
    Decision Date
    June 10, 1993
    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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