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

    Provisio™ SLT IVUS™ System

    K Number: K233948 · Decision Apr 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    131

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    Basic Information

    Device Name
    Provisio™ SLT IVUS™ System
    K Number
    K233948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Provisio Medical, Inc.
    Date Received
    December 14, 2023
    Decision Date
    April 23, 2024
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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