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

    Heli-FX EndoAnchor System

    K Number: K182957 · Decision Nov 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    Heli-FX EndoAnchor System
    K Number
    K182957
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3460
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Vascular, Inc.
    Date Received
    October 24, 2018
    Decision Date
    November 21, 2018
    Product Code
    OTD
    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
    OTD Endovascular Suturing System

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