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

    Cedar™ Endovenous Radiofrequency Catheters:
    Cedar™ Endovenous Radiofrequency Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

    Endovenous Radiofrequency Generator:
    The Endovenous Radiofrequency Generator is used with radiofrequency catheters intended for vessel coagulation.

    Device Description

    Like the predicate device, the Cedar Endovenous Radiofrequency Catheters are sterile, single use, disposable radiofrequency (RF) catheters with an integrated connection cable. The catheter has a 7F profile with a heating element (coil) available in two lengths, 3cm and 7cm with a 2.15mm diameter. The catheters include a 60cm working length and catheter positioning is achieved via the heating element with engraved marker. The catheter's function is to provide thermal energy to the desired treatment site through radiofrequency heating from the catheter heating element. The Cedar catheter is designed to be used with the Acotec Endovenous Radiofrequency Generator which is designed to provide controlled delivery of RF energy.

    The Endovenous Radiofrequency Generator is designed to provide controlled delivery of radiofrequency (RF) energy to RF catheters marketed by Acotec intended for vessel coagulation. The RF generator supplies and controls the RF energy delivered to the catheter and measures and displays RF output power and elapsed time of RF delivery. The generator also interfaces with a sensor in the catheter to provide a continuous display of measured patient temperature prior to and during RF delivery.

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