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

    BD POSIFLOW POSITIVE DISPLACEMENT VALVE

    K Number: K050207 · Decision Apr 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    36
    Review Days
    69

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    Basic Information

    Device Name
    BD POSIFLOW POSITIVE DISPLACEMENT VALVE
    K Number
    K050207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Infusion Therapy Systems, Inc.
    Date Received
    January 28, 2005
    Decision Date
    April 7, 2005
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPA Set, Administration, Intravascular

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