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

    14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT

    K Number: K991431 · Decision May 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    110
    Review Days
    30

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    Basic Information

    Device Name
    14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
    K Number
    K991431
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow Intl., Inc.
    Date Received
    April 26, 1999
    Decision Date
    May 26, 1999
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, Non-Implanted

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