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

    Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter

    K Number: K232584 · Decision Oct 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    4
    Review Days
    60

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    Basic Information

    Device Name
    Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
    K Number
    K232584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vein 360, LLC
    Date Received
    August 25, 2023
    Decision Date
    October 24, 2023
    Product Code
    OWQ
    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
    OWQ Reprocessed Intravascular Ultrasound Catheter

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    Other Clearances by Vein 360, LLC

    K Number Device Name
    K230928 Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
    K230584 Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
    K191073 Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter