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510(k) Data Aggregation

    K Number
    K051060
    Device Name
    ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    2005-05-26

    (30 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ANGIODYNAMICS Profiler™ PTA Balloon Catheter is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Angiodynamics, Inc. regarding their Profiler™ PTA Balloon Catheter. This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general controls. It does not detail specific performance studies or acceptance criteria for the device itself.

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