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

    MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.

    K Number: K891230 · Decision May 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    15
    Review Days
    73

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    Basic Information

    Device Name
    MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.
    K Number
    K891230
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Blood Systems, Inc.
    Date Received
    March 7, 1989
    Decision Date
    May 19, 1989
    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 Medtronic Blood Systems, Inc.

    K Number Device Name
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    K893207 CLOSED CHEST SUPPORT CIRCUIT
    K893678 DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
    K891687 EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
    K885154 INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
    K884390 INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER
    K884244 INTERSEPT* PREBYPASS FILTER
    K883439 INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
    K883086 INTERSEPT*PREBYPASS FILTER
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