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

    STERILE CORMED MEDIPORT

    K Number: K850967 · Decision May 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    STERILE CORMED MEDIPORT
    K Number
    K850967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cormed, Inc., Sub. C.R.Bard, Inc.
    Date Received
    March 8, 1985
    Decision Date
    May 17, 1985
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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

    K Number Device Name
    K863606 BUTTERFLY NON-CORING NEEDLE SET
    K860432 PERCUTANEOUS INTRODUCER KIT
    K854019 PORT-GARD
    K850674 CORMED II AMBULATORY INFUSION PUMP
    K843083 CORMED HUBER POINT NEEDLE
    K833915 VASCULAR ACCESS CATH. REPAIR KIT
    K823553 CORCATH H & B VASCULAR ACCESS CATHETER