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

    EPi-Ease Epicardial Access Device (EAS)

    K Number: K233959 · Decision Feb 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    59
    Review Days
    60

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    Basic Information

    Device Name
    EPi-Ease Epicardial Access Device (EAS)
    K Number
    K233959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AtriCure, Inc.
    Date Received
    December 15, 2023
    Decision Date
    February 13, 2024
    Product Code
    DYB
    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
    DYB Introducer, Catheter

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