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510(k) Data Aggregation

    K Number
    K192715
    Device Name
    CRF Radiofrequency Ablation System
    Date Cleared
    2020-01-07

    (102 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cambridge Interventional LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CRF Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue.
    Device Description
    The CRF Radiofrequency Ablation System consists of an RF generator, active electrode, grounding pad, and peristallic punp for electrode cooling. This device is designed to cal tissue heating at the tip of the electrode causing coagulation and ablation of tissue. The CRF Generator supplies radiofrequency energy at 480 kHz while monitoring both the tissue imperature at the CRF electrode tip. The CRF Generator monitors the power, resistance, current and temperature during energy delivery to the paient. The CRF Electrodes are sterile, single-use, hand-held for use in radiofrequency ablation procedures. The electrodes are surgically invasive, transient devices in patient contact typically for less than one hour. Cooling of the electrodes is provided by chilled sterile saline or water that is pumped through the electrode and out via outflow tubing. This is an enclosed system within the electrode and the saline does not contact. The CRF Generator automatically monitors impedance and temperature and adjusts RF output accordingly. The CRF Radiofrequency Ablation System is used in a healthcare facility or hospital setting.
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