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

    OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY

    K Number: K905646 · Decision Mar 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    4
    Review Days
    100

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    Basic Information

    Device Name
    OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY
    K Number
    K905646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Norfolk Medical
    Date Received
    December 17, 1990
    Decision Date
    March 27, 1991
    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 Norfolk Medical

    K Number Device Name
    K151341 Turbo High-Flow Non-coring Needle
    K111101 NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
    K911067 NORCATH VASCULAR ACCESS CATHETERS