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

    CARDIOTOMY RESERVOIR-FILTERED & NON

    K Number: K830727 · Decision Apr 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    CARDIOTOMY RESERVOIR-FILTERED & NON
    K Number
    K830727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Electromics, Inc.
    Date Received
    March 8, 1983
    Decision Date
    April 5, 1983
    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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    Other Clearances by Electromics, Inc.

    K Number Device Name
    K830728 CARDIOVASCULAR DISPOSABLE PRODUCTS