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

    EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS

    K Number: K842133 · Decision Feb 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    4
    Review Days
    265

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    Basic Information

    Device Name
    EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS
    K Number
    K842133
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cardio Search, Inc.
    Date Received
    May 30, 1984
    Decision Date
    February 19, 1985
    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 Cardio Search, Inc.

    K Number Device Name
    K841880 ERYTHROCATH UMBILICAL CATHETER
    K833873 CARDIOSEARCH RIGHT ATRIAL CATH-
    K832064 VENOUS CATHETER