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

    Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

    K Number: K233619 · Decision May 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    189

    Basic Information

    Device Name
    Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
    K Number
    K233619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesciences
    Date Received
    November 13, 2023
    Decision Date
    May 20, 2024
    Product Code
    DXE
    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
    DXE Catheter, Embolectomy

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