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

    Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

    K Number: K241388 · Decision Jan 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    32
    Review Days
    232

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    Basic Information

    Device Name
    Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
    K Number
    K241388
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    May 15, 2024
    Decision Date
    January 2, 2025
    Product Code
    QJP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QJP Catheter, Percutaneous, Neurovasculature

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