BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOSENSE WEBSTER, INC.

    Reg #: 3013300026 · FEI: 3013300026 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    117
    Establishment Types
    3
    Classifications
    11

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    3013300026
    FEI Number
    3013300026
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173978
    PMA Number
    P040036

    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

    Products

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

    Proprietary Names

    Carto 3 System and Accessories, version 5 with CARTOFINDER Preface Guiding Sheath OPTRELL Mapping Catheter with TRUEref Technology Biosense Webster LASSO Deflectable Mapping Catheter Coronary Sinus Deflectable Mapping Catheter CARTO 3 EP Navigation System & CARTO 3 External Reference Patches NaviStar RMT ThermoCool Catheter ThermoCool SF NAV CAtheter NaviStar ThermoCool Catheter ThermoCool SF NAV Bi-Directional Catheter EZ Steer ThermoCool NAV Catheter nGEN Generator Webster® catheter PENTARAY® NAV ECO High Density Mapping Catheter DECANAV® Mapping Catheter Webster® CS Catheter with Auto ID SoundStar 3D UlraSound Catheter EZ Steer DS Catheter EZ Steer DS NAV Catheter NaviStar DS Catheter NaviStar RMT DS Catheter Celsius DS Catheter Celsius RMT Catheter Celsius Catheter EZ Steer Catheter Cordis Webster Diagnostic Deflectable Tip Catheter CARTO 3 EP Navigation System with CARTOSOUND 4D v7/4 CARTO™ 3 EP Navigation System V8.1 Webster Duo-Decapolar Catheter 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 PentaRay NAV eco High-Density Mapping Catheter LASSO NAV CATHETER TX eco EXT Cable QDOT MICRO Catheter TX eco Cable Carto Octaray Mapping Catheter with TRUEref Technology CARTO 3 System eco Interface Cable CARTO 3 EP Navigation System Version 7.2 Sterile Interface Cable TRUPULSE™ Generator VARIPULSE™ Catheter CARTO 3 EP Navigation System, Version 6 CARTO™ 3 EP Navigation System V9 with PIU Plus RefStar External Reference Patch NuVision ICE Catheter; NUVISION Ultrasound Catheter NUVISION Connector Cable Cordis Webster PREFACE Braided Guiding Sheath and Perry Exchange Dilator Cordis Webster REF-STAR External Reference Patch OMNYPULSE Catheter Dual Energy THERMOCOOL SMARTTOUCH SF Catheter VARIPULSE Catheter REFSTAR PLUS with QWIKPATCH External REference Patch, REFSTAR PLUS Cable Webster Diagnostic Catheter LASSO 2515 NAV Variable Catheter, D-1290-01 and D-1290-02 TRUEPULSE Generator THERMOCOOL SMARTTOUCH SF CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath CARTO VIZIGO 8.5F Sheath with Curve Viz MdC, Short CARTO VIZIGO 8.5F Sheath with Curve Viz SmC, Short SoundStar eco 10F and SoundStar eco 10FG Catheter CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) Biosense Webster Patient Cable and Leadwires LASSOSTAR NAV Circular Mapping Catheter CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES Cordis Webster REF-STAR EX Surface Reference Device CS RefStar Catheter, DecaNav Catheter LASSO NAV Duo Loop Catheter PENTARAY High-Density Mapping Catheter, Models D-1245-01 and D-1245-02 (formerly Flower high-density mapping catheter) CARTO 3 system version 8 ESOPHASTAR Esophageal Mapping Catheter Cordis Webster Braided Guiding Sheath Exchange System Soundstar ECO 8FG Ultrasound Catheer, Soundstar ECO 8F Ultrasound Catheter NaviStar RMT Steerable Tip Diagnostic Catheter Pentaray Nav eco High-Density Mapping Catheter Switching Unit Electrode Catheters Webster CS Catheter with EZ Steer Technology Deflectable Braided Tip Electrode Catheter Ismus Catheter Webster 20 Pole Diagnostic Deflectable Tip Catheter Cordis Webster Fixed Curve Catheters CARTO 3 System and Accessories v7 SoundStar 3D Ultrasound Catheter NUVISION™ NAV Ultrasound Catheter CARTO 3 EP Navigation System V8.4 CARTO 3 EP Navigation System with Signal Processing Unit CARTO 3 System and Accessories, version 4.3.5 with Coherent Mapping LASSO 2515 V eco Variable Catheter and LASSO NAV Catheter Pentaray Nav High-Density Mapping Catheter SOUNDSTAR™ CRYSTAL Ultrasound Catheter LassoStar Circular Mapping Catheter Webster CS Catheter Webster CS Catheter with EZ Steer Technology and Auto ID Nuvision Ultrasound Catheter Nuvision Nav Ultrasound Catheter EZ Steer NAV Catheter NaviStar RMT Catheter NaviStar Catheter CARTO 3 System v6 with VISITAG SURPPOINT 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 Cardiovascular, Thermodilution Flow, Coronary Sinus Flow, Electrode Catheters LASSO 2515 Variable Circular Mapping Catheter Cordis Webster STAR Catheter

    Establishment Types

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