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

    CATHETER WITH INTRODUCER AND SYRINGES

    K Number: K915129 · Decision Apr 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    147

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    Basic Information

    Device Name
    CATHETER WITH INTRODUCER AND SYRINGES
    K Number
    K915129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Utah Pioneer Medical, Inc.
    Date Received
    November 13, 1991
    Decision Date
    April 8, 1992
    Product Code
    GCA
    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
    GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

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    Other Clearances by Utah Pioneer Medical, Inc.

    K Number Device Name
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