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

    EXEL SAFELET CATHETER

    K Number: K895768 · Decision Feb 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    18
    Review Days
    143

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    Basic Information

    Device Name
    EXEL SAFELET CATHETER
    K Number
    K895768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Exel Intl.
    Date Received
    September 26, 1989
    Decision Date
    February 16, 1990
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Exel Intl.

    K Number Device Name
    K992290 EXEL INJECTION PLUG WITH CAP
    K963658 EXEL AVF SINGLE NEEDLE
    K963659 EXEL I.V. ADMINISTRATION SET
    K926119 EXEL HUBER INFUSION SET ROTATING WING
    K904685 EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)
    K903945 EXEL A-V FISTULA SET
    K895770 EXEL HUBER INFUSION SET
    K895772 EXEL INDWELLING CATHETER
    K895771 EXEL SPINAL NEEDLES
    K895769 EXEL HUBER NEEDLE
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