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

    SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS

    K Number: K913526 · Decision Nov 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    27
    Review Days
    85

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    Basic Information

    Device Name
    SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
    K Number
    K913526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Althin Medical AB an Affiliate of Baxter Intl
    Date Received
    August 8, 1991
    Decision Date
    November 1, 1991
    Product Code
    FJK
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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