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510(k) Data Aggregation

    K Number
    K013384
    Device Name
    SHARGHP A.V. FISTULA NEEDLE SET
    Manufacturer
    SHARGH PHARMACEUTICAL CO., INC.
    Date Cleared
    2002-01-07

    (87 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is an A.V. Fistula Needle Set part of extracorporial artificial kidney system This device is an A. V. Fistula Noodle Det part of claims of the patient's blood vessel for Hemodialysis.

    Device Description

    SHARghP A.V. Fistula Needle Set

    AI/ML Overview

    The provided text is a clearance letter from the FDA for a medical device called "SHARghP A.V. Fistula Needle Set." This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    The letter is a regulatory document stating that the device has been determined to be "substantially equivalent" to legally marketed predicate devices, allowing its manufacturer to market it. It focuses on regulatory compliance rather than detailed performance data.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided input.

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