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510(k) Data Aggregation

    K Number
    K993913
    Device Name
    TRUE
    Manufacturer
    INFINITY EXTRUSION & ENGINEERING, INC.
    Date Cleared
    2000-08-09

    (266 days)

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

    **INFINITY EXTRUSION **& ENGINEERING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for Percutaneous Dilatation of the iliac, femoral, popliteal, tibial, renal, infra popliteal, ilio femoral, and tibiopernoeal arteries.
    Device Description
    The TRUE PTA Balloon Catheter is a non-reusable multiple lumen catheter with a balloon mounted on its distal tip. The TRUE PTA Balloon Catheter is packaged sterile and intended for single use only.
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