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

    Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

    K Number: K191073 · Decision Oct 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    4
    Review Days
    183

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    Basic Information

    Device Name
    Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter
    K Number
    K191073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vein 360, LLC
    Date Received
    April 22, 2019
    Decision Date
    October 22, 2019
    Product Code
    NUJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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    Other Clearances by Vein 360, LLC

    K Number Device Name
    K232584 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
    K230928 Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
    K230584 Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter