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

    TELET-LEX MEDICAL IV CATHETER PLACEMENT

    K Number: K851142 · Decision Jul 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    64
    Review Days
    106

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    Basic Information

    Device Name
    TELET-LEX MEDICAL IV CATHETER PLACEMENT
    K Number
    K851142
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Teleflexmedical, Inc.
    Date Received
    March 21, 1985
    Decision Date
    July 5, 1985
    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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