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

    GORE FLOW REVERSAL SYSTEM

    K Number: K083300 · Decision Feb 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    35
    Applicant Total
    163
    Review Days
    86

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    Basic Information

    Device Name
    GORE FLOW REVERSAL SYSTEM
    K Number
    K083300
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    November 10, 2008
    Decision Date
    February 4, 2009
    Product Code
    NTE
    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
    NTE Temporary Carotid Catheter For Embolic Capture

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    Other Clearances by W. L. Gore & Associates, Inc.

    K Number Device Name
    K250410 GORE® Tri-Lobe Balloon Catheter
    K240083 GORE® PROPATEN® Vascular Graft
    K232312 GORE® PROPATEN® Vascular Graft
    K233551 GORE® ACUSEAL Vascular Graft
    K231505 GORE® ACUSEAL Vascular Graft
    K191773 GORE BIO-A Tissue Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K173333 GORE ENFORM Biomaterial
    K163576 GORE SYNECOR Preperitoneal Biomaterial
    K170740 GORE VIABIL Short Wire Biliary Endoprosthesis
    Search all 163 clearances from W. L. Gore & Associates, Inc. →