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

    ELECTRODE CATHETER, ORTHOGONAL TYPE

    K Number: K841802 · Decision Oct 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    5
    Review Days
    170

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    Basic Information

    Device Name
    ELECTRODE CATHETER, ORTHOGONAL TYPE
    K Number
    K841802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Webster Laboratories, Inc.
    Date Received
    May 1, 1984
    Decision Date
    October 18, 1984
    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 Webster Laboratories, Inc.

    K Number Device Name
    K853383 CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
    K834602 SWITCHING UNIT ELECTRODE CATHETER
    K823361 SWITCHING UNIT ELECTRODE CATHETERS
    K813271 TEMPERATURE PROBES