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

    POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER

    K Number: K141531 · Decision Jun 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    566
    Review Days
    357

    Basic Information

    Device Name
    POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
    K Number
    K141531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    C.R. BARD, INC.
    Date Received
    June 9, 2014
    Decision Date
    June 1, 2015
    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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