BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARDIOFOCUS, INC.

    Reg #: 1225698 · FEI: 3001451473 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    CARDIOFOCUS, INC.
    Registration Number
    1225698
    FEI Number
    3001451473
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    500 NICKERSON ROAD, SUITE 500-200
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152310
    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
    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation OCM
    Catheter, Steerable DRA
    Introducer, Catheter DYB

    Proprietary Names

    HeartLight® System Centauri System HeartLight Deflectable Sheath

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility