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

    EXTRACORPOREAL SUBCLAVIAN CATHETER KIT

    K Number: K823752 · Decision Jan 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    69
    Review Days
    31

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    Basic Information

    Device Name
    EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
    K Number
    K823752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    December 14, 1982
    Decision Date
    January 14, 1983
    Product Code
    FIQ
    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
    FIQ Cannula, A-V Shunt

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    K833477 INTERSEPT 40 MICRON FILTER
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