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

    MODEL TRIEX-L HOLLOW FIBER DIALYZER

    K Number: K800549 · Decision Apr 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    69
    Review Days
    31

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    Basic Information

    Device Name
    MODEL TRIEX-L HOLLOW FIBER DIALYZER
    K Number
    K800549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    March 10, 1980
    Decision Date
    April 10, 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 Extracorporeal Medical Specialities, Inc.

    K Number Device Name
    K843955 EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
    K840532 HEMOPERFUSION SYSTEM TP-400
    K840262 HANCOCK PERICARDIAL PATCH
    K840146 EXP* 700 PARALLEL PLATE DIALYZER
    K840057 EXP* 500 PARALLEL PLATE DIALYZER
    K831423 THERAPEUTIC EXCHANGE SYSTEM
    K832547 ULTRAFILTRATION CONTROLLER
    K833477 INTERSEPT 40 MICRON FILTER
    K833476 INTERSEPT 40 MICRON FILTER W/TUBING
    K831424 THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
    Search all 69 clearances from Extracorporeal Medical Specialities, Inc. →