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

    8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER

    K Number: K910486 · Decision Apr 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    50
    Review Days
    72

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    Basic Information

    Device Name
    8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
    K Number
    K910486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Davol, Inc.
    Date Received
    February 6, 1991
    Decision Date
    April 19, 1991
    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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