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510(k) Data Aggregation

    K Number
    K972538
    Device Name
    FLOW-EZE BLUNT CANNULA (1999BC)
    Manufacturer
    ACACIA, INC.
    Date Cleared
    1998-07-15

    (372 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FLOW-EZE BLUNT CANNULA (1999BC)

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

    ACACIA'S Flow Eze Blunt Cannula for use with a sterile Acacia 3 riow mac bean medication into a Baxter's Interlink ) Injece meaze Blunt Cannula is single-use only. Split Septum.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "Flow-Eze Blunt Cannula." It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews that would typically be found in a study summary or a submission to the FDA detailing performance data.

    The letter is a regulatory approval notice, not a performance study report. Therefore, I cannot extract the requested information from the provided text. The questions posed pertain to the technical validation of a device's performance, which is not present in this regulatory correspondence.

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