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

    EXEL I.V. BLOOD LINE SET

    K Number: K992039 · Decision Feb 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    12
    Review Days
    238

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    Basic Information

    Device Name
    EXEL I.V. BLOOD LINE SET
    K Number
    K992039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Exelint Intl. Co.
    Date Received
    June 17, 1999
    Decision Date
    February 10, 2000
    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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    Other Clearances by Exelint Intl. Co.

    K Number Device Name
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    K020533 EXEL VACULET BLOOD COLLECTION SET
    K022406 EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET
    K011757 EXEL COMFORTPOINT INSULIN PEN NEEDLE
    K012879 EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
    K013037 EXCEL A.V FISUTAL NEEDLE SET
    K011405 EXEL INJECTION PLUG WITH CAP
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