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

    3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES

    K Number: K072697 · Decision Dec 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES
    K Number
    K072697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    3t Medical Systems, LLC
    Date Received
    September 24, 2007
    Decision Date
    December 20, 2007
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by 3t Medical Systems, LLC

    K Number Device Name
    K022287 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS
    K020768 3T VESSEL CANNULAS
    K020365 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
    K001245 3T L. V. CONTROL VALVE