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510(k) Data Aggregation

    K Number
    K042234
    Device Name
    MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
    Manufacturer
    SPECIALTY HEALTH PRODUCTS, INC.
    Date Cleared
    2004-09-08

    (21 days)

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

    SPECIALTY HEALTH PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The LiftLoc® Safety Infusion Set device is a safety intravascular administration . set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. - The integral LiftLock Safety Infusion Set safety mechanism is manually . activated during the removal of the LiftLoc® Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle. - The LiftLoc® Safety Infusion Set is intended for use in the administration of . fluids and drugs, or blood sampling through surgically implanted vascular ports. - The LiftLoc Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device. - The LiftLoc® Safety Infusion Set may be used in any appropriate patient ● population.
    Device Description
    The LiftLoc® Safety Infusion Set is a non-coring Huber needle and administration set with an integral safety needlestick prevention feature. The LiftLoc® Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The LiftLoc® Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only. The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad is also available as an optional accessory.
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