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

    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS

    K Number: K090101 · Decision Feb 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    645
    Review Days
    26

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    Basic Information

    Device Name
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
    K Number
    K090101
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    January 15, 2009
    Decision Date
    February 10, 2009
    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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