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510(k) Data Aggregation

    K Number
    K093271
    Device Name
    EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD
    Manufacturer
    VICTUS, INC.
    Date Cleared
    2010-01-27

    (100 days)

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

    VICTUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To administer IV fluids/medication to a patient's vascular system.
    Device Description
    The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.
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    K Number
    K030246
    Device Name
    VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072
    Manufacturer
    VICTUS, INC.
    Date Cleared
    2003-02-26

    (33 days)

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

    VICTUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To administer IV fluids/medication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.
    Device Description
    The Victus I.V. Administration Sets are single use, sterile, non-pyrogenic devices used to administer I.V. fluids/medication to a patient's vascular system via gravity control.
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    K Number
    K023469
    Device Name
    VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062
    Manufacturer
    VICTUS, INC.
    Date Cleared
    2002-12-10

    (55 days)

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

    VICTUS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To administer IV fluids/medication to the patient's vascular system.
    Device Description
    The Victus Administration Sets are single use, sterile, non-pyrogenic devices used to administer IV fluids/medication to a patient's vascular system via gravity control.
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