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

    MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0

    K Number: K984271 · Decision Mar 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    475
    Review Days
    99

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    Basic Information

    Device Name
    MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
    K Number
    K984271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Vascular
    Date Received
    November 30, 1998
    Decision Date
    March 9, 1999
    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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