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

    NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010

    K Number: K101194 · Decision Jul 11, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    6
    Review Days
    439

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    Basic Information

    Device Name
    NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
    K Number
    K101194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carticept Medical, Inc.
    Date Received
    April 28, 2010
    Decision Date
    July 11, 2011
    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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