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

    BALLOON RETENTION CHEST CATHETER

    K Number: K802025 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    37

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    Basic Information

    Device Name
    BALLOON RETENTION CHEST CATHETER
    K Number
    K802025
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Loseff Medical Designers, Ltd.
    Date Received
    August 20, 1980
    Decision Date
    September 26, 1980
    Product Code
    GBA
    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
    GBA Catheter, Balloon Type

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    Other Clearances by Loseff Medical Designers, Ltd.

    K Number Device Name
    K801349 LOSEFF BALLOON TYPE SELF-RETENTION WOUND