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

    CELSITE, MODELS ST401L, ST405L

    K Number: K994111 · Decision Jan 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    CELSITE, MODELS ST401L, ST405L
    K Number
    K994111
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    B. Braun/Mcgaw
    Date Received
    December 6, 1999
    Decision Date
    January 3, 2000
    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 B. Braun/Mcgaw

    K Number Device Name
    K983373 IMPACT BALLOON DILATION CATHETER