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510(k) Data Aggregation

    K Number
    K113622
    Device Name
    ORION II CT CVC
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
    Date Cleared
    2012-05-18

    (162 days)

    Product Code
    FOZ, REG
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORION™ II CT CVC is intended to be used by medical professionals for short-term access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. All ORION™ II CT CVC products have a maximum · recommended infusion rating of 5 ml/sec. The ORION™ II CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the ORION™ III CT CVC.
    Device Description
    The ORION™ II CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies, The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each ORION™ II CT CVC has a kink resistant, gradual tapered catheter design. The ORION™ II CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The ORION™ II CT CVC is indicated for dwell times shorter than 30 days. The ORION™ II CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. The ORION™ II CT CVC product line has catheters in 16 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All ORION™ II CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
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    K Number
    K070630
    Device Name
    HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE
    Manufacturer
    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
    Date Cleared
    2007-08-31

    (177 days)

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

    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow requlator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
    Device Description
    An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow requlator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
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