Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022451073

FEI Number

3022451073

Entity Name

BIOSENSE WEBSTER, INC.

City/State/Country

Irvine, CA, US

Establishment Address

23 Hubble Drive, Irvine, CA 92618, US

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

K180238

PMA Number

N/A

All Registered Proprietary Names

CARTO 3 EP Navigation System V8.4 CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) CARTO 3 EP Navigation System Version 7.2 CARTO 3 system version 8 CARTO 3 System v6 with VISITAG SURPPOINT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-03-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-09-12
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2021-11-02
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-06-26

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
9673241	BIOSENSE WEBSTER, INC.	JUAREZ Chihuahua, MX
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
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

Similar Registrations

Registration Number	Establishment Name	Location
3020036682	CARDIONXT	Westminster, CO, US
3031786139	B-SECUR LIMITED	Belfast, GB
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
3003084417	STEREOTAXIS, INC.	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022451073. Last updated year: 2026. Please use registration number 3022451073 when referencing this establishment in official correspondence.