BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MPS ACACIA POWER INJECTABLE INFUSION SET

    K Number: K090809 · Decision Apr 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    MPS ACACIA POWER INJECTABLE INFUSION SET
    K Number
    K090809
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mps Acacia
    Date Received
    March 25, 2009
    Decision Date
    April 28, 2009
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    Other Clearances by Mps Acacia

    K Number Device Name
    K080328 MPS ACACIA ENTERAL FEEDING TUBE
    K052946 MPS ACACIA NERVE BLOCK NEEDLE
    K052451 MPS ACACIA MEDFLO ELASTOMERIC PUMP
    K032934 MPS ACACIA SAFEGUARD HUBER DEVICE
    K011117 MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
    K003476 MPS ACACIA PAIN KIT