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

    DEKNATEL THORACIC CATHETER

    K Number: K852041 · Decision Jun 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    30
    Review Days
    39

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    Basic Information

    Device Name
    DEKNATEL THORACIC CATHETER
    K Number
    K852041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pfizer, Inc.
    Date Received
    May 9, 1985
    Decision Date
    June 17, 1985
    Product Code
    JOL
    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
    JOL Catheter And Tip, Suction

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