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510(k) Data Aggregation

    K Number
    K031783
    Device Name
    SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
    Manufacturer
    INTRAVASCULAR INCORPORATED
    Date Cleared
    2003-07-01

    (21 days)

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

    INTRAVASCULAR INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safe-Connect™ Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain fluid path integrity. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
    Device Description
    The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids.
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    K Number
    K023585
    Device Name
    FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000
    Manufacturer
    INTRAVASCULAR INCORPORATED
    Date Cleared
    2002-11-21

    (27 days)

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

    INTRAVASCULAR INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLOSTAR Needleless Connector device is sterile, disposable, needle-less I.V. access valve for use in intravenous administration of fluids to a patient's vascular system. The FLOSTAR Needleless Connector device may aid in the prevention of needle stick injuries.
    Device Description
    The FLOSTAR Needleless Connector is a sterile, disposable, needle-less I.V. access valve for use in general intravenous administration of fluids.
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