BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    BIOSENSE WEBSTER, INC.

    Reg #: 9673241 · FEI: 3003248396 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    96
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    9673241
    FEI Number
    3003248396
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CIRCUITO INTERIOR NORTE, No. 1820, PARQUE INDUSTRIAL SALVARCAR
    City
    JUAREZ Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K042998
    PMA Number
    P240006

    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
    Tucky Wong

    US Agent

    Business Name
    Biosense Webster Inc.
    Contact Name
    Tucky Wong
    Address
    31 Technology Dr. Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 2413161

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Introducer, Catheter DYB
    Computer, Diagnostic, Programmable DQK
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Cardiac Ablation Percutaneous Catheter LPB
    Catheter, Intracardiac Mapping, High-Density Array MTD
    Catheter, Flow Directed DYG
    Electrode, Pacemaker, Temporary LDF
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    RefStar External Reference Patch Sterile Interface Cable TRUPULSE™ Generator VARIPULSE™ Catheter Coronary Sinus Deflectable Mapping Catheter TRUEPULSE Generator THERMOCOOL SMARTTOUCH SF LASSO 2515 Variable Circular Mapping Catheter Cordis Webster Braided Guiding Sheath Exchange System Cordis Webster REF-STAR External Reference Patch Webster CS Catheter Webster CS Catheter with EZ Steer Technology Webster CS Catheter with EZ Steer Technology and Auto ID CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES SmartAblate RF Generator and Accessories Stockert 70 RF-Generator for Cardiac Ablation SmartAblate Irrigation Tubing Set nGEN Pump Sterile Interface Cables for use with the Stockert 70 Radiofrequency Generator OPTRELL Mapping Catheter with TRUEref Technology Cordis Webster PREFACE Braided Guiding Sheath and Perry Exchange Dilator ESOPHASTAR Esophageal Mapping Catheter EZ Steer DS Catheter EZ Steer DS NAV Catheter NaviStar DS Catheter NaviStar RMT DS Catheter Celsius DS Catheter nGEN Generator Ismus Catheter Webster 20 Pole Diagnostic Deflectable Tip Catheter NaviStar RMT ThermoCool Catheter ThermoCool SF NAV CAtheter NaviStar ThermoCool Catheter ThermoCool SF NAV Bi-Directional Catheter EZ Steer ThermoCool NAV Catheter CS RefStar Catheter, DecaNav Catheter Webster® catheter PENTARAY® NAV ECO High Density Mapping Catheter DECANAV® Mapping Catheter Webster® CS Catheter with Auto ID Cardiovascular, Thermodilution Flow, Coronary Sinus Flow, Electrode Catheters Electrode Catheter Orthogonal Type TX eco EXT Cable QDOT MICRO Catheter TX eco Cable Biosense Webster Patient Cable and Leadwires NuVision ICE Catheter; NUVISION Ultrasound Catheter NUVISION Connector Cable EZ Steer NAV Catheter NaviStar RMT Catheter NaviStar Catheter Webster Duo-Decapolar Catheter Cordis Webster Diagnostic Deflectable Tip Catheter Nuvision Ultrasound Catheter Nuvision Nav Ultrasound Catheter Cordis Webster Fixed Curve Catheters PENTARAY High-Density Mapping Catheter, Models D-1245-01 and D-1245-02 (formerly Flower high-density mapping catheter) REFSTAR PLUS with QWIKPATCH External REference Patch, REFSTAR PLUS Cable Carto Octaray Mapping Catheter with TRUEref Technology CARTO 3 System eco Interface Cable Cordis Webster REF-STAR EX Surface Reference Device Deflectable Braided Tip Electrode Catheter Pentaray Nav High-Density Mapping Catheter NUVISION™ NAV Ultrasound Catheter LASSO 2515 NAV Variable Catheter, D-1290-01 and D-1290-02 Preface Guiding Sheath 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 ThermoCool SF Catheter Celsius ThermoCool Catheter ThermoCool SF Bi-Directional Catheter ThermoCool SF NAV Catheter EZ Steer ThermoCool Catheter Celsius RMT ThermoCool Catheter LASSO 2515 V eco Variable Catheter and LASSO NAV Catheter Celsius RMT Catheter Celsius Catheter EZ Steer Catheter PentaRay NAV eco High-Density Mapping Catheter LassoStar Circular Mapping Catheter OMNYPULSE Catheter Dual Energy THERMOCOOL SMARTTOUCH SF Catheter VARIPULSE Catheter Cordis Webster STAR Catheter Pentaray Nav eco High-Density Mapping Catheter Switching Unit Electrode Catheters LASSO NAV CATHETER Webster Diagnostic Catheter Biosense Webster LASSO Deflectable Mapping Catheter LASSOSTAR NAV Circular Mapping Catheter LASSO NAV Duo Loop Catheter NaviStar RMT Steerable Tip Diagnostic Catheter

    Establishment Types

    Manufacture Medical Device