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510(k) Data Aggregation

    K Number
    K121083
    Device Name
    TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
    Manufacturer
    LOMA VISTA MEDICAL
    Date Cleared
    2012-10-11

    (184 days)

    Product Code
    OZT
    Regulation Number
    870.1255
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOMA VISTA MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRUE Dilatation™ Catheter is indicated for balloon aortic valvuloplasty.
    Device Description
    The Loma Vista Medical (LVM) TRUE Dilatation™ Catheter is a coaxial catheter with a balloon fixed at the tip used for Balloon Aortic Valvuloplasty (BAV) of the aortic valve. The effective length of the catheter is 110 cm and it has two lumens: one lumen is used to inflate and deflate the balloon and the other permits the use of a guidewire to position the catheter. The balloon inflation luer-lock hub (angled) connects to a syringe inflation device to deliver radiopaque contrast media for inflation. The guidewire luer-lock hub (straight) connects to the guidewire lumen.
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