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

    XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

    K Number: K193495 · Decision May 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    164

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    Basic Information

    Device Name
    XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
    K Number
    K193495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Transit Scientific
    Date Received
    December 17, 2019
    Decision Date
    May 29, 2020
    Product Code
    PNO
    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
    PNO Catheter, Percutaneous, Cutting/Scoring

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    Other Clearances by Transit Scientific

    K Number Device Name
    K193420 XO Cross Support Catheter