Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050600
    Device Name
    MINILOC SAFETY INFUSION SET
    Manufacturer
    SPECIALIZED HEALTH PRODUCTS, INTL.
    Date Cleared
    2005-05-12

    (64 days)

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

    SPECIALIZED HEALTH PRODUCTS, INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The MiniLoc™ 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 MiniLoc™ Safety Infusion Set safety mechanism is manually . activated during the removal of the MiniLoc™ 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 MiniLoc™ Safety Infusion Set is intended for use in the administration of . fluids and drugs, as well as blood sampling through surgically implanted ports. - The MiniLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device. - The MiniLoc™ Safety Infusion Set may be used in any appropriate patient . population.
    Device Description
    The MiniLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The MiniLocTM 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 MiniLocTM Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.
    Ask a Question

    Page 1 of 1