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

    INTRASTENT LD (LARGE DIAMETER) STENT

    K Number: K020528 · Decision Apr 16, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    8
    Review Days
    56

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    Basic Information

    Device Name
    INTRASTENT LD (LARGE DIAMETER) STENT
    K Number
    K020528
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Sulzer Intratherapeutics, Inc.
    Date Received
    February 19, 2002
    Decision Date
    April 16, 2002
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Sulzer Intratherapeutics, Inc.

    K Number Device Name
    K023243 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K021729 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K021563 INTRACOIL SELF-EXPANDING PERIPHERAL STENT
    K014136 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K011806 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K012347 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K012066 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY