BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HeartLight® System

    Reg #: 1225698 · FEI: 3001451473 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARDIOFOCUS, INC.
    Registration Number
    1225698
    FEI Number
    3001451473
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 NICKERSON ROAD, SUITE 500-200
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    PMA Number
    P150026

    Owner / Operator

    Firm Name
    CARDIOFOCUS, INC.
    Operator Number
    9026178
    Address
    500 NICKERSON ROAD, SUITE 500-200
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    HeartLight® System

    Establishment Types

    Manufacture Medical Device