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510(k) Data Aggregation

    K Number
    K981547
    Device Name
    NFC NEEDLEFREE Y-SITE, MODEL 69970
    Manufacturer
    FILTERTEK, INC.
    Date Cleared
    1998-06-18

    (49 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    FILTERTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NFC Y-Site is for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The Needlefree side port of the y-site is swabbable and can be accessed multiple times using a male Luer for the purpose of administering general IV solutions or blood.
    Device Description
    The Filtertek NFC Needlefree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use. The Filtertek NFC Needlefree Y-Site is a sterile, non-pyrogenic component packaged in a Twek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Y-Site have been tested per tripartite guidelines and are safe for their intended use.
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    K Number
    K981548
    Device Name
    NFC NEEDLEFREE CONNECTOR MODEL 69900
    Manufacturer
    FILTERTEK, INC.
    Date Cleared
    1998-06-18

    (49 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    FILTERTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used as a needless injection port that can be attre hed to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.
    Device Description
    The Filtertek NFC Needlefree Connector is a one-piece design. luer interfacing injection port. It is sterile, nonpyroqenic and packaged in a Tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Filtertek NFC Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use.
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