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

    PERITONEAL CATHETERS WITH AN ADDED FUNCTION

    K Number: K890288 · Decision Mar 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    164
    Review Days
    67

    Basic Information

    Device Name
    PERITONEAL CATHETERS WITH AN ADDED FUNCTION
    K Number
    K890288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    QUINTON, INC.
    Date Received
    January 19, 1989
    Decision Date
    March 27, 1989
    Product Code
    FJS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FJS Catheter, Peritoneal, Long-Term Indwelling

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