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510(k) Data Aggregation

    K Number
    K180558
    Device Name
    PressureWire X
    Manufacturer
    St. Jude Medical (now part of Abbott Medical)
    Date Cleared
    2018-03-28

    (27 days)

    Product Code
    DXO, DQX, DRG
    Regulation Number
    870.2870
    Why did this record match?
    Applicant Name (Manufacturer) :

    St. Jude Medical (now part of Abbott Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.
    Device Description
    The PressureWire™ X guidewire has an integrated sensor element at the tip to enable measurements of physiological parameters. The wire is introduced into the patient's blood vessel. A torque device is used to steer the wire and sensor into the required position for pressure measurements according to standard clinical practice. PressureWire™ X guidewire is available in two different lengths. The guidewire is uniquely paired with a specific connection cable or with a specific transmitter. Both PressureWire™ X guidewire connection configurations connect to a diagnostic computer or a catheter laboratory hemodynamic recording system. The PressureWire™ guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is transmitted to associated equipment for analysis, calculations, and display of physiological parameters or indices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).
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