BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NAVISTAR THERMOCOOL CATHETER

    Reg #: 3013300026 · FEI: 3013300026 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    3013300026
    FEI Number
    3013300026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    PMA Number
    P030031

    Owner / Operator

    Firm Name
    BIOSENSE WEBSTER, INC.
    Operator Number
    9044811
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Maria Jose Arana

    Products

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

    Proprietary Names

    NAVISTAR THERMOCOOL CATHETER ThermoCool SmartTouch SF Bi-Directional Navigation Catheter ThermoCool SmartTouch SF Uni-Directional Navigation Catheter ThermoCool SmartTouch Uni-Directional Ablation Catheter ThermoCool SmartTouch Navigation Catheter VISITAG SURPOINT™ EPU NaviStar RMT ThermoCool Catheter EZ Steer ThermoCool Catheter ThermoCool SF Bi-Directional Catheter ThermoCool SF NAV Bi-Directional Catheter ThermoCool SF Catheter Celsius RMT ThermoCool Catheter EZ Steer ThermoCool NAV Catheter Celsius ThermoCool Catheter ThermoCool SF NAV Catheter nGEN Generator

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility