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

    3T L. V. CONTROL VALVE

    K Number: K001245 · Decision Aug 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    484

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    Basic Information

    Device Name
    3T L. V. CONTROL VALVE
    K Number
    K001245
    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
    April 18, 2000
    Decision Date
    August 15, 2001
    Product Code
    MJJ
    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
    MJJ Cpb Check Valve, Retrograde Flow, In-Line

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    Other Clearances by 3t Medical Systems, LLC

    K Number Device Name
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    K020768 3T VESSEL CANNULAS
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