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

    POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6

    K Number: K061356 · Decision Jul 3, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    63
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
    K Number
    K061356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6885
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Infusion, Inc.
    Date Received
    May 15, 2006
    Decision Date
    July 3, 2006
    Product Code
    MED
    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
    MED Sterilant, Medical Devices

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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
    K042246 MULTI-DRIP INFUSION CATHETER
    K021964 ALPHA INFUSION PUMP AND CATHETERS
    K992551 ALPHA INFUSION PUMP