Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9673241

FEI Number

3003248396

Entity Name

BIOSENSE WEBSTER, INC.

City/State/Country

JUAREZ Chihuahua, MX

Establishment Address

CIRCUITO INTERIOR NORTE, No. 1820, PARQUE INDUSTRIAL SALVARCAR, JUAREZ Chihuahua 32574, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOSENSE WEBSTER, INC. (Owner Number: 9044811)

Owner / Operator Contact Address

31 Technology Drive, Suite 200, --, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120425

PMA Number

N/A

All Registered 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 Webster CS Catheter with EZ Steer Technology 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 nGEN Generator 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 nGEN Generator Biosense Webster Patient Cable and Leadwires NuVision ICE Catheter; NUVISION Ultrasound Catheter NUVISION Connector Cable EZ Steer NAV Catheter nGEN Generator NaviStar RMT Catheter NaviStar Catheter OPTRELL Mapping Catheter with TRUEref Technology 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-11-28
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-11-07
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	2017-02-23
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
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	2009-10-19
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2009-10-20
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	2022-03-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	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
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
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
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-04-03
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
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2007-11-28
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2007-11-28
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
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	2023-09-11
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
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2023-03-06
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
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-09-26
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	2007-11-28
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-04-10
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2020-08-06
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
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2012-06-06

Official Correspondent

Tucky Wong

US Agent Details

Tucky Wong Business: Biosense Webster Inc. Email: twong13@its.jnj.com Phone: (949) 2413161

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
3008203003	Biosense Webster (Israel), Ltd.	Yokneam Northern, IL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9673241. Last updated year: 2026. Please use registration number 9673241 when referencing this establishment in official correspondence.