BEUDAMED
    FDA Registration Active 🇱🇻 Latvia

    Auryon Atherectomy Catheter 1.5mm - Hydrophilic coated

    Reg #: 3016445722 · FEI: 3016445722 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSMUNDS
    Registration Number
    3016445722
    FEI Number
    3016445722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Siltuma iela 4
    City
    Riga
    Country
    LV

    Regulatory Submissions

    510(k) Number
    K233668

    Owner / Operator

    Firm Name
    Osmunds
    Operator Number
    10056745
    Address
    Siltuma iela 4
    City
    Riga
    State
    LV-RIX
    Postal Code
    LV 1058
    Country
    LV

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    Auryon Atherectomy Catheter 1.5mm - Hydrophilic coated Auryon Atherectomy Catheter 2.35mm OTW Auryon Atherectomy Catheter 1.5mm OTW Auryon Atherectomy Catheter 2mm OTW Auryon Atherectomy Catheter 0.9mm - Hydrophilic coated Auryon Atherectomy Catheter 0.9mm OTW Auryon Atherectomy Catheter 2mm - Hydrophilic coated Auryon Atherectomy Catheter 2.35mm - Hydrophilic coated Auryon Atherectomy Catheter 0.9mm, XL (Extra long) - Hydrophilic coated Auryon Atherectomy Catheter 1.5mm, XL (Extra long) Auryon Atherectomy Catheter 1.5mm, XL (Extra long) - Hydrophilic coated Auryon Laser System - for Infra Inguinal Atherectomy

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)