BEUDAMED
    FDA Registration Active 🇱🇻 Latvia

    2.35 mm Auryon" Atherectomy Catheter with aspiration

    Reg #: 3012669557 · FEI: 3012669557 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LIGHT GUIDE OPTICS INTERNATIONAL LTD.
    Registration Number
    3012669557
    FEI Number
    3012669557
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Celtniecibas street 8
    City
    Livani Preilu Novads
    Country
    LV

    Regulatory Submissions

    510(k) Number
    K220116

    Owner / Operator

    Firm Name
    Light Guide Optics International Ltd.
    Operator Number
    10050996
    Address
    Celtniecibas street 8
    City
    Livani
    State
    Preilu Novads
    Postal Code
    LV 5316
    Country
    LV
    Correspondent
    Santa Vucina

    US Agent

    Business Name
    LightGuideOptics USA, LLC
    Contact Name
    Mick Speciale
    Address
    1101 South Winchester Blvd., Suite L-238
    City
    San Jose
    State
    CA
    ZIP
    95128
    Country
    US
    Email
    [email protected]
    Phone
    408 8237111

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    2.35 mm Auryon" Atherectomy Catheter with aspiration 2 mm Auryon" Atherectomy Catheter with aspiration 0.9 mm Auryon" Atherectomy Catheter without aspiration 1.5 mm Auryon" Atherectomy Catheter without aspiration

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)