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

    E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET

    K Number: K970259 · Decision Apr 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    25
    Review Days
    75

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    Basic Information

    Device Name
    E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
    K Number
    K970259
    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 Vascular Access, Inc.
    Date Received
    January 23, 1997
    Decision Date
    April 8, 1997
    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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