BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Therapy Cool Path Duo Ablation Catheter

    Reg #: 2030404 · FEI: 1000519796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IRVINE BIOMEDICAL. INC.
    Registration Number
    2030404
    FEI Number
    1000519796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2375 Morse Ave
    City
    IRVINE
    State
    CA
    ZIP
    92614
    Country
    US

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD

    Proprietary Names

    Therapy Cool Path Duo Ablation Catheter Ampere Remote Control Contact Therapy Cool Path Duo Ablation Catheter Safire Duo Ablation Catheter, MediGuide Enabled Ampere Generator Kit Therapy Cool Flex Ablation Catheter Cool Path Duo Ablation Catheter, MediGuide Enabled Therapy Dual-8 Ablation Catheter Therapy Cool Path Ablation Catheter Ampere Generator Ampere Generator Generator Accessories Cool Point™ Irrigation Pump

    Establishment Types

    Manufacture Device in the United States for Export Only