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

    CORMED II AMBULATORY INFUSION PUMP

    K Number: K850674 · Decision Apr 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    8
    Review Days
    48

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    Basic Information

    Device Name
    CORMED II AMBULATORY INFUSION PUMP
    K Number
    K850674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cormed, Inc., Sub. C.R.Bard, Inc.
    Date Received
    February 20, 1985
    Decision Date
    April 9, 1985
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Cormed, Inc., Sub. C.R.Bard, Inc.

    K Number Device Name
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    K860432 PERCUTANEOUS INTRODUCER KIT
    K854019 PORT-GARD
    K850967 STERILE CORMED MEDIPORT
    K843083 CORMED HUBER POINT NEEDLE
    K833915 VASCULAR ACCESS CATH. REPAIR KIT
    K823553 CORCATH H & B VASCULAR ACCESS CATHETER