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

    ORION II CT CVC

    K Number: K113622 · Decision May 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    212
    Registration Numbers
    213
    Same Product Code
    496
    Applicant Total
    2
    Review Days
    162

    Basic Information

    Device Name
    ORION II CT CVC
    K Number
    K113622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
    Date Received
    December 8, 2011
    Decision Date
    May 18, 2012
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by HEALTH LINE INTERNATIONAL CORPORATION (HLIC)

    K Number Device Name
    K070630 HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE