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

    CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)

    K Number: K964989 · Decision Apr 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    6
    Review Days
    110

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    Basic Information

    Device Name
    CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
    K Number
    K964989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Critical Device Corp.
    Date Received
    December 13, 1996
    Decision Date
    April 2, 1997
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Critical Device Corp.

    K Number Device Name
    K983926 MPS GRAVITY FLOW CONTROL SET
    K964918 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
    K964812 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
    K952852 NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
    K955896 MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11