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

    HeRO Graft, HeRO Adapter

    K Number: K203724 · Decision May 25, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    178
    Review Days
    155

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    Basic Information

    Device Name
    HeRO Graft, HeRO Adapter
    K Number
    K203724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    December 21, 2020
    Decision Date
    May 25, 2021
    Product Code
    DSY
    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
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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