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510(k) Data Aggregation

    K Number
    K033858
    Device Name
    TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
    Manufacturer
    EUROPEAN CUSTOM MANUFACTURING BV
    Date Cleared
    2004-07-12

    (214 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed. The wire may be used on either the atrium or ventricle.

    Device Description

    Temporary Bipolar Myocardial Pacing Wire

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria. The document is a 510(k) clearance letter from the FDA for a "Temporary Bipolar Myocardial Pacing Wire," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory information and indications for use but does not include details about device testing or study results.

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