BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

    K Number: K033858 · Decision Jul 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    2
    Review Days
    214

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    Basic Information

    Device Name
    TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
    K Number
    K033858
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    European Custom Manufacturing BV
    Date Received
    December 11, 2003
    Decision Date
    July 12, 2004
    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 European Custom Manufacturing BV

    K Number Device Name
    K080621 FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01