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510(k) Data Aggregation

    K Number
    K062192
    Device Name
    OSTIAL PRO STENT POSITIONING SYSTEM
    Manufacturer
    OSTIAL SOLUTIONS, LLC
    Date Cleared
    2007-05-24

    (297 days)

    Product Code
    DQX, PRO
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSTIAL SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.
    Device Description
    The Ostial Pro Stent Positioning System is a medical grade, disposable guidewire system. The Ostial Pro Stent Positioning System will be used by interventional cardiologists and interventional radiologists to ensure precise stent implantation in aorta-ostial procedures. The product will be used in coronary and renal stenting procedures. The product is provided sterile and intended for single use. This finished product will be compatible with 6, 7 and 8 French catheters.
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