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510(k) Data Aggregation

    K Number
    K060119
    Device Name
    MCKINLEY SATURATION CATHETER
    Manufacturer
    MCKINLEY MEDICAL LLC
    Date Cleared
    2006-04-12

    (85 days)

    Product Code
    FRN, BSO
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCKINLEY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The McKinley Saturation Catheter™ is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.
    Device Description
    The McKinley Saturation Catheter™ is a single patient use disposable infusion catheter, intended for connection to an infusion device, used to deliver pain medication to a patient for pain management. The McKinley Saturation Catheter™ is a flexible, tubular infusion catheter with multiple holes located throughout the fenestrated segment along the distal end of the catheter. The catheter will be available in different sizes (varying length of fenestrated segment, number of holes, diameter of catheter body), as appropriate for use in a variety of catheter placements. The McKinley Saturation Catheter™ connects to an infusion device via a proximal luerlock connector.
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    K Number
    K050770
    Device Name
    MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
    Manufacturer
    MCKINLEY MEDICAL LLC
    Date Cleared
    2005-04-14

    (20 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCKINLEY MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue/body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative, perioperative, and postoperative surgery. The Accufuser and Accufuser Plus systems are also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous. The Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites. The Accufuser and Accufuser Plus systems are intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
    Device Description
    The Accufuser device consists of an elastomeric balloon medication reservoir with a flow rate-controlling administration set. The pressure that pumps the fluid is derived from the strain energy of the elastomeric membrane that is forced to expand when the pump is filled. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently. The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician variety of product on thow rate and reservoir size based on the individual patient needs. Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been rctivated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed. A procedure kit option provides various components that facilitate setup and use of the Accufuser system. The Accufuser system is intended for single patient use.
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