BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CATAPRESS TOURNIGUET

    K Number: K852277 · Decision Jun 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    335
    Registration Numbers
    335
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    CATAPRESS TOURNIGUET
    K Number
    K852277
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5900
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Date Received
    May 29, 1985
    Decision Date
    June 27, 1985
    Product Code
    GAX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAX Tourniquet, Nonpneumatic

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