FOXCONN BAJA CALIFORNIA S.A DE C.V.

FDA Device Registration & Listing · tijuana Baja California, MX · Registration 3008093809

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
3008093809
FEI Number
3008093809
Entity Name
FOXCONN BAJA CALIFORNIA S.A DE C.V.
City/State/Country
tijuana Baja California, MX
Establishment Address
Laguna Mainar 5520. El lago Tijuana, Baja California 22210 Mexico, tijuana Baja California 22210, MX
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
FOXCONN BAJA CALIFORNIA S.A DE C.V. (Owner Number: 10060158)
Owner / Operator Contact Address
Laguna Mainar 5520. El Lago Tijuana, Baja California 22210 Mexico, Tijuana, MX-BCN 22210, MX
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TX eco EXT Cable nMARQ Catheter Interface Cable BWI Affinity Cables nMARQ Catheter Interface Cable BWI Small Dome BWI EZ Steer Class II BWI Affinity Cable nMARQ Catheter Interface Cable BWI Affinity Cable BWI Lasso Nav

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2024-11-26
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2024-11-26
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2024-11-26
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2024-11-26
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-11-26
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2025-12-03
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2024-11-26
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-04-29
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-11-14
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-06-27
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2024-11-26
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2024-11-26
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2024-11-26
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-12-21

Official Correspondent

Francisco Lepe

US Agent Details

Korina Akhondzadeh Business: KARA & Associates Email: korina@kara2a.com Phone: (858) 3448168

Related Public Records

Same Entity

FOXCONN BAJA CALIFORNIA S.A DE C.V.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
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

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 3008093809. Last updated year: 2026. Please use registration number 3008093809 when referencing this establishment in official correspondence.
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