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510(k) Data Aggregation

    K Number
    K161171
    Device Name
    PressureWire X Guidewire
    Manufacturer
    ST. JUDE MEDICAL INC.
    Date Cleared
    2016-08-15

    (111 days)

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

    ST. JUDE MEDICAL INC.

    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.
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