Biosense Webster (Israel), Ltd.

FDA Device Registration & Listing · Yokneam Northern, IL · Registration 3008203003

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
3008203003
FEI Number
3008203003
Entity Name
Biosense Webster (Israel), Ltd.
City/State/Country
Yokneam Northern, IL
Establishment Address
4 Hatnufa Street, Yokneam Northern 2066717, IL
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
N
Expiration Date (Year)
2026
510(k) Number
K072202
PMA Number
N/A

All Registered Proprietary Names

CARTO 3 EP Navigation System with Signal Processing Unit CARTO 3 EP Navigation System, Version 6 CARTO 3 System v6 with VISITAG SURPPOINT CARTO 3 System and Accessories, version 4.3.5 with Coherent Mapping CARTO 3 EP Navigation System Version 7.2 CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES TruDi Navigation System V3 CARTO™ 3 EP Navigation System V8.1 CARTO ENT System TruDi Navigation System CARTO™ 3 EP Navigation System V9 with PIU Plus TruDi Navigation System, Rev 1.3 CARTO 3 System and Accessories v7 CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) CARTO 3 EP Navigation System & CARTO 3 External Reference Patches

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-11-30
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2017-08-09
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-06-26
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2018-09-13
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2021-11-02
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2009-10-20
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2023-07-26
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-08-27
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2017-02-06
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2020-02-05
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-01-28
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2018-03-26
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-06-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-09-12
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2007-11-26

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
9673241 BIOSENSE WEBSTER, INC. JUAREZ Chihuahua, MX
3013300026 BIOSENSE WEBSTER, INC. Irvine, CA, US

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 3008203003. Last updated year: 2026. Please use registration number 3008203003 when referencing this establishment in official correspondence.
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