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

    ESTECH CLEARVIEW MV ATRIAL DEPRESSOR

    K Number: K053021 · Decision Jan 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    92

    Basic Information

    Device Name
    ESTECH CLEARVIEW MV ATRIAL DEPRESSOR
    K Number
    K053021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4420
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ESTECH, INC.
    Date Received
    October 26, 2005
    Decision Date
    January 26, 2006
    Product Code
    DTS
    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
    DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass

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