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510(k) Data Aggregation

    K Number
    K211327
    Device Name
    Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
    Manufacturer
    Date Cleared
    2022-02-10

    (283 days)

    Product Code
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    CathRxLtd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.
    Device Description
    Khelix Diagnostic Electrophysiology Catheters are a range of electrophysiology diagnostic cardiac catheters designed to facilitate electrophysiological mapping of the heart. The devices are intended for the electrical recording and/or stimulation of endocardial structures. The device consists of a catheter handle and catheter shaft containing an array of platinum-iridium electrodes for stimulation and recording. The subject device comes in a variety of models based on the distal catheter configuration including Steerable and Loop models. The device interfaces with standard electrophysiological recording equipment, such as ECG monitoring equipment, impedance based navigational equipment and cardiac stimulation equipment, via the Khelix Diagnostic Extension Cable (supplied separately). The device is available in different device models with several variants according to electrode configurations, curve types and loop diameters, as applicable. The subject catheters use 4 to 20 electrodes with variable spacing to provide for variation in physician preference. The catheter is intended to be used with the Khelix Diagnostic Extension Cable. The extension cable connects distally to the catheter (sterile field) and proximally to standard electrophysiology (EP) laboratory equipment such as heart signal monitors/records and stimulators (non-sterile field) via shielded tip pins. The Khelix Diagnostic Electrophysiology Catheter range is supplied sterile. The devices are sterilized using an ethylene oxide (EtO) sterilization process.
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