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510(k) Data Aggregation

    K Number
    K173581
    Device Name
    Gallant PTCA Dilatation Catheter
    Manufacturer
    Medinol, Ltd.
    Date Cleared
    2018-01-25

    (66 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medinol, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gallant PTCA Dilatation Catheter is indicated for: • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; • Post-deployment stent expansion.
    Device Description
    The Gallant is a sterile, single-use, intravascular medical device. The Gallant is a combination of single lumen and dual lumen catheter comprising an expandable semi-compliant (SC) coronary balloon on a rapid exchange (RX) catheter.
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