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

    CF/211 CAPILLARY FLOW DIALYZER, #5M1784

    K Number: K800221 · Decision Feb 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    206
    Review Days
    22

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    Basic Information

    Device Name
    CF/211 CAPILLARY FLOW DIALYZER, #5M1784
    K Number
    K800221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    February 4, 1980
    Decision Date
    February 26, 1980
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

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    Other Clearances by Travenol Laboratories, S.A.

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    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
    K871908 IV ADMINISTRATION SET
    K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
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