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

    Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

    K Number: K260105 · Decision Jun 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    21
    Review Days
    143

    Basic Information

    Device Name
    Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
    K Number
    K260105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesciences
    Date Received
    January 13, 2026
    Decision Date
    June 5, 2026
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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