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

    MODIFICATION TO VAXCEL DIALYSIS CATHETER

    K Number: K012948 · Decision Oct 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    MODIFICATION TO VAXCEL DIALYSIS CATHETER
    K Number
    K012948
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific/Medi-Tech
    Date Received
    September 4, 2001
    Decision Date
    October 3, 2001
    Product Code
    MSD
    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
    MSD Catheter, Hemodialysis, Implanted

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