BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇮🇹 Italy

    S80 IMPLANTABLE CARDIAC PACING LEAD

    K Number: K854963 · Decision Jun 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    20
    Review Days
    195

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    Basic Information

    Device Name
    S80 IMPLANTABLE CARDIAC PACING LEAD
    K Number
    K854963
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    December 11, 1985
    Decision Date
    June 24, 1986
    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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