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    K Number
    K091624
    Device Name
    STENT GRAFT BALLOON CATHETER
    Manufacturer
    VIA BIOMEDICAL, INC.
    Date Cleared
    2009-10-15

    (134 days)

    Product Code
    DQY, MJN
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIA BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.
    Device Description
    The Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm. The device is available in two usable lengths, 65 cm and 100 cm. The device is designed to accommodate a 0.038" diameter or smaller guidewire. Two radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The device is a single use, sterile device.
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