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

    VISION HOLLOW FIBER OXYGENATOR WITH HA COATING

    K Number: K080708 · Decision Feb 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    75
    Review Days
    327

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    Basic Information

    Device Name
    VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
    K Number
    K080708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gish Biomedical, Inc.
    Date Received
    March 12, 2008
    Decision Date
    February 2, 2009
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Gish Biomedical, Inc.

    K Number Device Name
    K090449 MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
    K090450 MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
    K091062 MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
    K083131 MEDOS HILITE RESERVOIR, MODEL: 4030
    K082403 MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
    K082082 GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
    K081947 GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
    K081838 GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
    K081881 GISH TUBING AND CONNECTORS WITH HA COATING
    K081054 GISH ARTERIAL FILTER WITH HA COATING
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