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

    POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE

    K Number: K844803 · Decision Apr 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    41
    Review Days
    139

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    Basic Information

    Device Name
    POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
    K Number
    K844803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Electromedics, Inc.
    Date Received
    December 11, 1984
    Decision Date
    April 29, 1985
    Product Code
    DTP
    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
    DTP Defoamer, Cardiopulmonary Bypass

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