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

    AVECOR PRE-BYPASS FILTER

    K Number: K940126 · Decision Jun 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    9
    Review Days
    169

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    Basic Information

    Device Name
    AVECOR PRE-BYPASS FILTER
    K Number
    K940126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avecor Cardiovascular, Inc.
    Date Received
    January 10, 1994
    Decision Date
    June 28, 1994
    Product Code
    KRJ
    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
    KRJ Filter, Prebypass, Cardiopulmonary Bypass

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