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

    TERUMO LAUER LOCK ADAPTER

    K Number: K093992 · Decision May 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    29
    Review Days
    146

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    Basic Information

    Device Name
    TERUMO LAUER LOCK ADAPTER
    K Number
    K093992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corporation
    Date Received
    December 24, 2009
    Decision Date
    May 19, 2010
    Product Code
    DTL
    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
    DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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