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

    POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER

    K Number: K083675 · Decision Mar 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    11
    Applicant Total
    645
    Review Days
    98

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    Basic Information

    Device Name
    POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
    K Number
    K083675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    December 11, 2008
    Decision Date
    March 19, 2009
    Product Code
    NIE
    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
    NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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