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510(k) Data Aggregation

    K Number
    K980992
    Device Name
    IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
    Manufacturer
    VENETEC INTL., INC.
    Date Cleared
    1998-05-28

    (72 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES

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

    An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a medical device, specifically "Starluck® IV Extension Sets with Needleless Access Devices." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

    Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is an administrative document related to market approval, focusing on regulatory classification and substantial equivalence, not performance testing details.

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

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