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

    TRIMPORT

    K Number: K974533 · Decision May 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    4
    Review Days
    156

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    Basic Information

    Device Name
    TRIMPORT
    K Number
    K974533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gerard Medical, Inc.
    Date Received
    December 2, 1997
    Decision Date
    May 7, 1998
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Gerard Medical, Inc.

    K Number Device Name
    K972555 CATHETER TUNNELER
    K945060 HERNIA MESH INTRODUCTION SYSTEM
    K936207 ENDO-NEEDLE INSTRUMENT