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

    CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER

    K Number: K042504 · Decision Jan 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    12
    Review Days
    491

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    Basic Information

    Device Name
    CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
    K Number
    K042504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myco Medical Supplies, Inc.
    Date Received
    September 15, 2004
    Decision Date
    January 19, 2006
    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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