BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VEIN360

    Reg #: 3015988948 · FEI: 3015988948 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    VEIN360
    Registration Number
    3015988948
    FEI Number
    3015988948
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4460 Lake Forest Dr, STE 218
    City
    Blue Ash
    State
    OH
    ZIP
    45242
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230928

    Owner / Operator

    Firm Name
    Vein360
    Operator Number
    10061626
    Address
    4460 LAKE FOREST DR, STE 218
    City
    Cincinnati
    State
    OH
    Postal Code
    45242
    Country
    US
    Correspondent
    Suzanne Meyer

    Products

    Device Name Product Code
    Reprocessed Intravascular Ultrasound Catheter OWQ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ

    Proprietary Names

    Vein360 Reprocessed Visions PV18 Digital IVUS Catheter Vein360 Reprocessed Visions PV35 Digital IVUS Catheter Vein360 Reprocessed Visions PV14P Rx Digital IVUS Catheter (014R) Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter Vein360 Reprocessed Visions PV14P Rx Digital IVUS Catheter (014P)

    Establishment Types

    Reprocess Single-Use Device