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

    XO CROSS CORONARY Support Catheter

    K Number: K214107 · Decision Apr 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    5
    Review Days
    103

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    Basic Information

    Device Name
    XO CROSS CORONARY Support Catheter
    K Number
    K214107
    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, LLC
    Date Received
    December 29, 2021
    Decision Date
    April 11, 2022
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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    Other Clearances by Transit Scientific, LLC

    K Number Device Name
    K232258 XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
    K231821 XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
    K221986 XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
    K210322 XO Cross Support Catheter