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

    PreludeSYNC DISTAL Radial Compression System

    K Number: K180723 · Decision Apr 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    178
    Review Days
    29

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    Basic Information

    Device Name
    PreludeSYNC DISTAL Radial Compression System
    K Number
    K180723
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    March 19, 2018
    Decision Date
    April 17, 2018
    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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