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510(k) Data Aggregation

    K Number
    K232261
    Device Name
    TME Temporary Myocardial Electrode
    Manufacturer
    Osypka AG
    Date Cleared
    2024-04-26

    (270 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Osypka AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.
    Device Description
    OSYPKA TME® temporary myocardial electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. The conductors or wires are typically 60cm or 220cm long and can be fixated to the heart either with the help of a suture (V-hook ), or directly with the attached heart needle (zigzag, and tines fixation types). The heart needle is cut off after fixation (Zigzag, Tines anchor) and disposed of. The thoracic needle is used to lead the wires to the outside of the patient's body to allow connection to the external pulse generator. The thoracic needle(s) is then also disposed of. OSYPKA TMEs are supplied as unipolar, bipolar, and quadripolar version. There are two options for connection to an external cardiac pacemaker or cable: with 2 mm adapter or Confix. The preassembled Confix connectors can be connected directly to an extension lead or to the cardiac pacemaker after the thorax needle has been cut off. The device is supplied sterile, non-pyrogenic and intended for single use only.
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