BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Auryon™Laser System - for Infra Inguinal Atherectomy

    Reg #: 3014443747 · FEI: 3014443747 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    EXIMO MEDICAL LTD
    Registration Number
    3014443747
    FEI Number
    3014443747
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pekeris St. 3
    City
    Rehovot Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K233668

    Owner / Operator

    Firm Name
    AngioDynamics
    Operator Number
    10058638
    Address
    26 Forest St.
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    US Agent

    Business Name
    AngioDynamics, Inc.
    Contact Name
    David Greer
    Address
    603 Queensbury Ave
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US
    Email
    [email protected]
    Phone
    518 7951676

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    Auryon™Laser System - for Infra Inguinal Atherectomy Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW Auryon Atherectomy Catheter 1.5mm - Hydrophilic Coated AURYON ATHERECTOMY CATHETER 1.5 MM OTW AURYON ATHERECTOMY CATHETER 0.9 MM OTW AURYON ATHERECTOMY CATHETER 2 MM OTW Auryon Atherectomy Catheter 2mm - Hydrophilic Coated Auryon Atherectomy Catheter 2.35mm - Hydrophilic Coated Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW - Hydrophilic Coating Auryon Atherectomy Catheter 0.9mm - Hydrophilic Coated AURYON ATHERECTOMY CATHETER 2.35 MM OTW Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198