BEUDAMED
    FDA Registration Active 🇱🇻 Latvia

    Auryon Atherectomy Catheter 1.5mm OTW

    Reg #: 3012669557 · FEI: 3012669557 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    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
    K233668

    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

    Auryon Atherectomy Catheter 1.5mm OTW Auryon Atherectomy Catheter 0.9mm, XL (Extra long) Auryon Atherectomy Catheter 0.9mm, XL (Extra long) - Hydrophilic coated Auryon Atherectomy Catheter 2.35mm OTW Auryon Atherectomy Catheter 2mm - Hydrophilic coated Auryon Atherectomy Catheter 0.9mm OTW Auryon Atherectomy Catheter 0.9mm - Hydrophilic coated Auryon Atherectomy Catheter 1.5mm - Hydrophilic coated Auryon Atherectomy Catheter 2.35mm - Hydrophilic coated Auryon Atherectomy Catheter 2.mm OTW Auryon Atherectomy Catheter 1.5mm, XL (Extra long) - Hydrophilic coated Auryon Atherectomy Catheter 1.5mm, XL (Extra long)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)