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510(k) Data Aggregation

    K Number
    K013037
    Device Name
    EXCEL A.V FISUTAL NEEDLE SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2001-12-07

    (88 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXCEL A.V FISUTAL NEEDLE SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THIS DEVICE IS AN A.V. FISTULA NEEDLE SET PART OF EXTRACORPORIAL ARTICICAL IS THE FOR SYSTEM FOR THE TREATHENTS WITH RENAL PALLURE TO PROVIDE ACCESS TO THE PATIENT'S BLOOD VESSEL FOR HEMODIALYSIS.

    Device Description

    EXEL A.V. FISTULA NEEDLE SET

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device called the "EXEL A.V. Fistula Needle" and does not contain information about acceptance criteria or a study proving its performance. The document is an FDA letter confirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include details on specific performance metrics, clinical studies, or the types of information requested in the prompt.

    Therefore, I cannot provide the requested information based on the provided text.

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