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

    Surfacer Inside-Out Access Catheter System

    K Number: K252527 · Decision Sep 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    30

    Basic Information

    Device Name
    Surfacer Inside-Out Access Catheter System
    K Number
    K252527
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1342
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Merit Medical System, Inc.
    Date Received
    August 11, 2025
    Decision Date
    September 10, 2025
    Product Code
    QJH
    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
    QJH Reverse Central Venous Recanalization System

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