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510(k) Data Aggregation

    K Number
    K251375

    Validate with FDA (Live)

    Device Name
    PuraCath Firefly Needleless Connector IT (9005)
    Manufacturer
    Puracath Medical, Inc.
    Date Cleared
    2026-02-12

    (286 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    0 - 21
    Reference & Predicate Devices
    K203796
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PuraCath™ Firefly™ Needleless Connector IT is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

    Device Description

    The PuraCath™ Firefly™ Needleless Connector IT is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration. PuraCath Medical received clearance for the predicate Firefly Needleless Connector (9001) under K203796. PuraCath would like to inform the FDA that two minor changes have been made to the predicate Firefly Needless Connector. Although most of the components and processes are identical for the two designs, minor modifications involve a slightly shorter and lighter design, resulting in the subject Firefly Needleless Connector IT. The PuraCath Firefly Needleless Connector IT is a neutral displacement needleless connector intended for connection to the female luer port(s) of a vascular access catheter. The Firefly Needleless Connector IT is for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The Firefly Needleless Connector IT is a closed, luer activated device. This means that when the Firefly Needleless Connector IT is attached to the female luer of the vascular access catheter, the valve remains closed until the ISO male luer of the accessing syringe, extension set, or standard administration set activates the flow of fluid through the needleless connector. The PuraCath Firefly Needleless Connector IT does not require a specific clamping sequence or technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. There is no interstitial or dead space internal to the connector.

    AI/ML Overview

    N/A

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