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

    VENTED MILLEX -GV, CATHIVEX -GV

    K Number: K133004 · Decision Mar 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    183

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    Basic Information

    Device Name
    VENTED MILLEX -GV, CATHIVEX -GV
    K Number
    K133004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5130
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merck Millipore , Ltd.
    Date Received
    September 25, 2013
    Decision Date
    March 27, 2014
    Product Code
    BSN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSN Filter, Conduction, Anesthetic

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    Other Clearances by Merck Millipore , Ltd.

    K Number Device Name
    K143583 Cathivex ¿GV filter units