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510(k) Data Aggregation

    K Number
    K233948
    Device Name
    Provisio™ SLT IVUS™ System
    Manufacturer
    Provisio Medical, Inc.
    Date Cleared
    2024-04-23

    (131 days)

    Product Code
    OBJ, DQY, ITX, IYO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Provisio Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Provisio™ SLT IVUS™ System is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature. The Provisio™ SLT IVUS™ System is designed for use as an adjunct to conventional angiographic procedures to evaluate the vessel lumen and provide dimensional measurements. The SLT IVUS™ Support Crossing Catheter also guides and supports a guidewire during access of the vasculature and provides a conduit for the delivery of saline solutions or radiopaque contrast agents.
    Device Description
    The Provisio™ Sonic Lumen Tomography Intravascular Ultrasound ("SLT IVUS™") System is an IVUS system that utilizes A-mode ultrasound operation to evaluate the vessel lumen and provide dimensional measurements in real time. The Provisio™ SLT IVUS™ System comprises the SLT IVUS™ Support Crossing Catheter and the SLT IVUS™ P1 System, which includes the Pulser Receiver Unit, the Display Unit, and a Cart. The SLT IVUS™ Support Crossing Catheters, provided sterile for single use, are over-the-wire intravascular ultrasound catheters with a digital ultrasound transducer array at the distal end. The information from the echoes is used to generate real-time dimensions and representations of the peripheral vessel's flow lumen. If required clinically, the SLT IVUS™ Support Crossing Catheter also functions as a support crossing catheter and may be used for the infusion of saline or radiopaque contrast agents. The Provisio™ SLT IVUS™ System may be used in peripheral vascular procedures to generate real-time measurements of the vessel flow lumen dimensions, while also providing the functionality of the support crossing catheter in the same procedure. The cross-sectional parameters of diameter and area are displayed as numbers; additionally, the diameter measurement is graphically displayed as a representation of the flow lumen. The cross-sectional area measurements are displayed over time on a timeline display. As the catheter is moved by the operator through the vessel lumen, new crosssectional measurements are obtained and displayed. Adjacent cross-sectional measurements can be compiled and displayed over a period of time to create an orthogonal graphical display of the vessel lumen (called RunView™).
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