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510(k) Data Aggregation

    K Number
    K090300
    Device Name
    MODIFICATION TO AUTOFUSER
    Manufacturer
    ACE MEDICAL US, LLC
    Date Cleared
    2009-04-30

    (83 days)

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

    ACE MEDICAL US, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites. Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
    Device Description
    The Autofuser system consists of a family of disposable infusion pumps and associated procedure kits. The pump is comprised of a balloon-style medication reservoir and an integrated flowrate-controlling administration set. When the Autofuser pump is packaged in a procedure kit, the kit includes legally marketed components such as filling syringe, catheter, catheter introducer, and pump carrying pouch.
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    K Number
    K060258
    Device Name
    AUTOFUSER
    Manufacturer
    ACE MEDICAL US, LLC
    Date Cleared
    2006-05-30

    (118 days)

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

    ACE MEDICAL US, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Autofuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, is intended for general infusion use. Routes of administration include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into intra-operative (soft tissue/body cavity) sites. Within the Autofuser family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.
    Device Description
    The modification to the existing device is the addition of new flow rates, new reservoir size and procedure kit components.
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