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

    MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900

    K Number: K080679 · Decision Jun 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    7
    Review Days
    109

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    Basic Information

    Device Name
    MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
    K Number
    K080679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Viasys Medsystems
    Date Received
    March 10, 2008
    Decision Date
    June 27, 2008
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Viasys Medsystems

    K Number Device Name
    K081725 ENTERAL PUMP SET, MODEL 20-1010
    K063061 CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
    K043044 ANTI-I.V. ENTERAL FEEDING SYSTEM
    K050309 PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
    K043004 STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
    K041987 CORTRAK