BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    14F DUAL FLOATING DIALYSIS CATHETER/TRAY

    K Number: K042672 · Decision Mar 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    5
    Review Days
    175

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    Basic Information

    Device Name
    14F DUAL FLOATING DIALYSIS CATHETER/TRAY
    K Number
    K042672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardio Med Supplies, Inc.
    Date Received
    September 29, 2004
    Decision Date
    March 23, 2005
    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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