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

    FLEX-NECK PD CATHETER

    K Number: K970159 · Decision Sep 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    5
    Review Days
    232

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    Basic Information

    Device Name
    FLEX-NECK PD CATHETER
    K Number
    K970159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Janin Group, Inc.
    Date Received
    January 16, 1997
    Decision Date
    September 5, 1997
    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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    Other Clearances by Janin Group, Inc.

    K Number Device Name
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