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

    GORE® Tri-Lobe Balloon Catheter

    K Number: K250410 · Decision Jun 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    163
    Review Days
    109

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    Basic Information

    Device Name
    GORE® Tri-Lobe Balloon Catheter
    K Number
    K250410
    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
    February 13, 2025
    Decision Date
    June 2, 2025
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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

    K Number Device Name
    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
    K163217 GORE BIO-A Tissue Reinforcement
    Search all 163 clearances from W. L. Gore & Associates, Inc. →