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

    DualCap IV Pole Strips(Disinfectant Caps for Male Luers)

    K Number: K142399 · Decision Nov 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    21
    Applicant Total
    7
    Review Days
    84

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    Basic Information

    Device Name
    DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
    K Number
    K142399
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Catheter Connections, Inc.
    Date Received
    August 27, 2014
    Decision Date
    November 19, 2014
    Product Code
    QBP
    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
    QBP Cap, Device Disinfectant

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    Other Clearances by Catheter Connections, Inc.

    K Number Device Name
    K142806 DualCap
    K123967 CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS
    K123065 CATHETER CONNECTIONS DUALCAP SOLO
    K113842 CATHETER CONNECTIONS' DUALCAP SOLO
    K112985 CATHETER CONNECTIONS' DUALCAP DUO
    K093229 CATHETER CONNECTIONS DUALCAP