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

    XEMEX TEMPORARY PACING CATHETER A MODIFIED

    K Number: K913521 · Decision Dec 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    3
    Review Days
    143

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    Basic Information

    Device Name
    XEMEX TEMPORARY PACING CATHETER A MODIFIED
    K Number
    K913521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zeon Medical Corp.
    Date Received
    August 6, 1991
    Decision Date
    December 27, 1991
    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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    Other Clearances by Zeon Medical Corp.

    K Number Device Name
    K905573 XEMEX ENTERAL NUTRITION CATHETER NASOGAS. TYPE A
    K904868 XEMEX TEMPORARY PACING CATHETER A