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

    ALPHA INFUSION PUMP AND CATHETERS

    K Number: K021964 · Decision Aug 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    87
    Applicant Total
    6
    Review Days
    59

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    Basic Information

    Device Name
    ALPHA INFUSION PUMP AND CATHETERS
    K Number
    K021964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Infusion, Inc.
    Date Received
    June 14, 2002
    Decision Date
    August 12, 2002
    Product Code
    MEB
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MEB Pump, Infusion, Elastomeric

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    Other Clearances by Advanced Infusion, Inc.

    K Number Device Name
    K071532 ALPHA INFUSION PUMP, MODEL A200, A450
    K061661 STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
    K061356 POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
    K042246 MULTI-DRIP INFUSION CATHETER
    K992551 ALPHA INFUSION PUMP