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

    RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV

    K Number: K832558 · Decision Nov 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    212
    Registration Numbers
    213
    Same Product Code
    496
    Applicant Total
    20
    Review Days
    119

    Basic Information

    Device Name
    RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV
    K Number
    K832558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    DESERET MEDICAL, INC.
    Date Received
    August 1, 1983
    Decision Date
    November 28, 1983
    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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    Other Clearances by DESERET MEDICAL, INC.

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    K904122 INSYTE-A ARTERIAL CATHETERIZATION UNIT
    K900116 DESERET OPTIMA INTRAVASCULAR CATHETER
    K895735 DESERET MULTILUMEN SUBCLAVIAN CATHETER
    K895734 DESERET INTRAVASCULAR CATHETER
    K894033 DISPOSABLE CATHETER PRESSURE TRANSDUCER
    K893406 DESERET PRN ADAPTER
    K882798 MULTIFLO ADAPTER
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