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

    VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238

    K Number: K031844 · Decision Jul 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    285
    Applicant Total
    430
    Review Days
    29

    Basic Information

    Device Name
    VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
    K Number
    K031844
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOSTON SCIENTIFIC CORP.
    Date Received
    June 16, 2003
    Decision Date
    July 15, 2003
    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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