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

    NMI PICC III and NMI PICC IV

    K Number: K150448 · Decision Mar 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    297
    Applicant Total
    34
    Review Days
    27

    Basic Information

    Device Name
    NMI PICC III and NMI PICC IV
    K Number
    K150448
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NAVILYST MEDICAL, INC.
    Date Received
    February 20, 2015
    Decision Date
    March 19, 2015
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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