BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    COMCASET SAFETY IV CATHETER

    K Number: K062108 · Decision Aug 8, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    2
    Review Days
    15

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    Basic Information

    Device Name
    COMCASET SAFETY IV CATHETER
    K Number
    K062108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pitango Medical, Ltd.
    Date Received
    July 24, 2006
    Decision Date
    August 8, 2006
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    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 Pitango Medical, Ltd.

    K Number Device Name
    K070020 COMCASET-P SAFETY IV CATHETER