BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SoundBite® Crossing System XS Peripheral

    K Number: K230159 · Decision Aug 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    221

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    Basic Information

    Device Name
    SoundBite® Crossing System XS Peripheral
    K Number
    K230159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Soundbite Medical Solutions, Inc.
    Date Received
    January 19, 2023
    Decision Date
    August 28, 2023
    Product Code
    PDU
    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
    PDU Catheter For Crossing Total Occlusions

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    Other Clearances by Soundbite Medical Solutions, Inc.

    K Number Device Name
    K210839 SoundBite Crossing System - Peripheral (14P)