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

    EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR

    K Number: K843955 · Decision Nov 29, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    69
    Review Days
    51

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    Basic Information

    Device Name
    EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR
    K Number
    K843955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    October 9, 1984
    Decision Date
    November 29, 1984
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Extracorporeal Medical Specialities, Inc.

    K Number Device Name
    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
    K832053 SINGLE PATIENT SYS. II MODEL DM-450
    Search all 69 clearances from Extracorporeal Medical Specialities, Inc. →