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

    LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING

    K Number: K053589 · Decision Apr 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    21
    Review Days
    111

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    Basic Information

    Device Name
    LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING
    K Number
    K053589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Access Systems, Inc.
    Date Received
    December 23, 2005
    Decision Date
    April 13, 2006
    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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