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

    SMARTSITE STOPCOCK

    K Number: K071400 · Decision Dec 14, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    9
    Review Days
    207

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SMARTSITE STOPCOCK
    K Number
    K071400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health, Alaris Products
    Date Received
    May 21, 2007
    Decision Date
    December 14, 2007
    Product Code
    FMG
    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
    FMG Stopcock, I.V. Set

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FMG), ordered by most recent decision date.

    Qitexio® 4-Way Stopcock (QIT014)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Three Way Stop Cock

    FDA 510(k)
    FDA Class 2 ·General Hospital

    lntravascular Administration Sets with Stopcock and Manifold

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SafePort(TM) Manifold (or Stopcock)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Clicky Cross

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Cardinal Health, Alaris Products

    K Number Device Name
    K071108 TEXIUM SYRINGE
    K061285 SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
    K053049 ALARIS SAFETY MALE LUER
    K052790 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
    K051641 ALARIS SYSTEM PC UNIT, MODEL 8001
    K050115 BLOOD HAND PUMP ADMINISTRATION SET
    K043590 SE INFUSION SYSTEM WITH MMS
    K050230 TURBO TEMP TRIO