BIOSENSE WEBSTER, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3013300026

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013300026
FEI Number
3013300026
Entity Name
BIOSENSE WEBSTER, INC.
City/State/Country
Irvine, CA, US
Establishment Address
31 Technology Drive, Suite 200, --, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
BIOSENSE WEBSTER, INC. (Owner Number: 9044811)
Owner / Operator Contact Address
31 Technology Drive, Suite 200, --, Irvine, CA 92618, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K252972
PMA Number
N/A

All Registered 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 nGEN Generator Celsius RMT Catheter nGEN Generator 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 nGEN Generator 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-09-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-28
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2022-03-21
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2007-11-26
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2007-11-28
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2024-05-09
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-05-09
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2010-06-23
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2007-10-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2007-11-28
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-03-08
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-08-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2011-05-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2007-11-28
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2007-11-28
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2013-07-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2010-06-23
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2022-12-07
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2022-12-07
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2020-08-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-11-02
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2024-11-07
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2017-08-09
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-01-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-09-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2017-02-23
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2009-04-10
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2008-10-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2009-01-08
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2017-02-23
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-10-19
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2012-03-21
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-09-12
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2007-11-28
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2009-10-20
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2022-02-24
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2009-10-20
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2009-04-03
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-08-17
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2007-11-28
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-09-20
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-28
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2014-03-14
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2022-04-04
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2010-06-23
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2007-11-28
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2009-12-11
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2023-02-24
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-03-02

Official Correspondent

Tucky Wong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BIOSENSE WEBSTER, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3022451073 BIOSENSE WEBSTER, INC. Irvine, CA, US
9673241 BIOSENSE WEBSTER, INC. JUAREZ Chihuahua, MX
3008203003 Biosense Webster (Israel), Ltd. Yokneam Northern, IL

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935043 Siemens Medical Electronics SIEMENS CLINICAL WORK STATION 1995-04-07
K170948 Acutus Medical, Inc. AcQMap High Resolution Imaging and Mapping System 2017-10-16
K242016 ABBOTT MEDICAL EnSite™ X EP System 2024-08-09
K172182 St. Jude Medical (Now Part of the Abbott Medical) QUANTIEN Measurement System 2017-08-18
K252013 ABBOTT MEDICAL EnSite™ X EP System 2025-09-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2016 Biosense Webster, Inc. 2
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013300026. Last updated year: 2026. Please use registration number 3013300026 when referencing this establishment in official correspondence.
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