Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2030404

FEI Number

1000519796

Entity Name

IRVINE BIOMEDICAL. INC.

City/State/Country

IRVINE, CA, US

Establishment Address

2375 Morse Ave, IRVINE, CA 92614, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Safire TX Ablation Catheter Safire Duo Ablation Catheter, MediGuide Enabled Therapy Cool Path Duo Ablation Catheter Therapy Cool Flex Ablation Catheter Ampere Generator Kit Ampere Generator Cool Path Duo Ablation Catheter, MediGuide Enabled Therapy Dual-8 Ablation Catheter Therapy Cool Path Ablation Catheter Contact Therapy Cool Path Duo Ablation Catheter Ampere Generator Generator Accessories Ampere Remote Control Cool Point Irrigation Pump Therapy Ablation Catheter ENSITE-R-SYS-04 EnSite X EP System ENSITE-SYSTEM-04 EnSite X EP System ENSITE-D-ADASLA-01 ADAS 3D LA License Temporary Software License ENSITE-ADASLV-01 ADAS 3D LV License Software License ENSITE-CECG-60-01 EnSite X EP System ECG Cable ENSITE-OTAC-02 EnSite X EP System OTA Certificate Software License ENSITE-ECGOUT-01 EnSite X EP System ECG Output Module ENSITE-SW-1.1 EnSite X EP System Software Upgrade ENSITE-IMP-01 EnSite X EP System, Averaged Impedance Drop, Software License ENSITE-D-LV-01 EnSite X EP System EnSite LiveView Dynamic Display Demo Software License ENSITE-SW-1.1.1 EnSite X EP System Software Upgrade ENSITE-SW-03 EnSite X EP System Software Upgrade ENSITE-MONPOLE-01 EnSite X EP System Monitor Pole ENSITE-SW-3.1 EnSite X EP System, Software Upgrade ENSITE-FF-ABRKT-01 EnSite Adjustable Field Frame Bracket ENSITE-ACBL-60-01 EnSite X EP System Connect Cable ENSITE-AMPCART3-01 EnSite X EP System Amplifier Cart ENSITE-FF-4.5C-01 EnSite X EP System Field Frame Cable ENSITE-DWSCART-01 EnSite X EP System Display Workstation Cart ENSITE-SMMK-01 EnSite X EP System Single Monitor Mount ENSITE-TFM-03 EnSite X EP System, TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-R-AMP-01 EnSite X EP System Amplifier ENSITE-TFM-3.1 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade ENSITE-AMD-01 EnSite X EP System, AutoMark Distance, Software License ENSITE-WM64-60-01 EnSite X EP System IC Output Cable ENSITE-DWS-3.1 EnSite X EP System, Display Workstation ENSITE-CF-01 EnSite X EP System Contact Force Software License ENSITE-FF-01 EnSite X EP System Field Frame ENSITE-SYSTEM-3.1 EnSite X EP System ENSITE-AAF-01 EnSite X Amplifier Air Filter ENSITE-SW-1.1.2 EnSite X EP System, Software Upgrade ENSITE-R-FF-01 EnSite X EP System Field Frame ENSITE-FWV-02 EnSite X EP System, EnSite PFA Catheter Visualization Software License ENSITE-D-LS-01 EnSite X EP System, LiveSync Demo, Software License ENSITE-RMS-01 EnSite X EP System Remote Monitor Stand ENSITE-OT-01 EnSite X EP System EnSite Omnipolar Technology Software License ENSITE-SYSTEM-201 EnSite X EP System ENSITE-ACBL-160-01 EnSite X EP System Connect Cable ENSITE-DWS-1.1 EnSite X EP System Display Workstation ENSITE-OTAC-01 EnSite X EP System OTA Certificate Software License ENSITE-GENECG-NAM EnSite X EP System PFA ECG Signal Splitter ENSITE-WM64-144-01 EnSite X EP System IC Output Cable ENSITE-HDGX-01 EnSite X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled, Software License ENSITE-D-AMD-01 EnSite X EP System, AutoMark Distance Demo, Software License ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License ENSITE-SEK-5-01 EnSite X EP System Surface Electrode Kit ENSITE-SW-2 EnSite X EP System Software Upgrade ENSITE-CECG-144-01 EnSite X EP System ECG Cable ENSITE-D-IMP-01 EnSite X EP System, Averaged Impedance Drop Demo, Software License ENSITE-DWS-2.1 EnSite X EP System Display Workstation ENSITE-R-DWS-3.1 EnSite X EP System, Display Workstation ENSITE-AMP-EPM-01 EnSite X EP System Amplifier Power Module ENSITE-R-SYS-3.1 EnSite X EP System ENSITE-D-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License ENSITE-R-DWS-04 EnSite X EP System Display Workstation ENSITE-SW-3.2 EnSite X EP System Software Upgrade v3.2 ENSITE-WM56-144-01 EnSite X EP System IC Output Cable ENSITE-D-FWV-02 EnSite X EP System EnSite PFA Catheter Visualization Temporary Software License ENSITE-ADAS-01 ADAS 3D Base License Software License ENSITE-AMP-02 EnSite X EP System Amplifier ENSITE-R-DWS-1.1 EnSite X EP System Display WorkStation ENSITE-D-FLEX-01 EnSite X EP System, VoXel Flex Demo, Software License ENSITE-TMMK-01 EnSite X EP System Triple Monitor Mount Kit ENSITE-D-OT-01 EnSite X EP System EnSite Omnipolar Technology Demo Software License ENSITE-D-FWV-01 EnSite X EP System, EnSite PFA Catheter Visualization Temporary, Software License ENSITE-FF-3MC-01 EnSite X EP System Field Frame Cable ENSITE-SW-3.1.1 EnSite X EP System Software Upgrade ENSITE-FWV-03 EnSite X EP System EnSite PFA Catheter Visualization Software License ENSITE-ECGRO-01 EnSite X EP System Radio-opaque ECG Lead set ENSITE-FF-BRCKT-01 EnSite Fixed Field Frame Bracket ENSITE-CR-56-01 EnSite X EP System Recording System IC Output Cable ENSITE-TFM-3.2 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade ENSITE-FLEX-01 EnSite X EP System, VoXel Flex, Software License ENSITE-CL-01 EnSite X EP System EnSite Cloud Software License ENSITE-R-DWS-01 EnSite X EP System Display Workstation ENSITE-TFM-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade ENSITE-R-DWS-2.1 EnSite X EP System Display Workstation ENSITE-D-WS-01 EnSite X EP System Wave Speed Map Demo Software License ENSITE-CR-64-01 EnSite X EP System Recording System IC Output Cable ENSITE-ECGRL-01 EnSite X EP System, Radio-lucent ECG Lead Set ENSITE-LE-01 EnSite X EP System Live Export Software License ENSITE-DMMK-01 EnSite X EP System Dual Monitor Mount ENSITE-DWS-01 EnSite X EP System Display Workstation ENSITE-AMP-01 EnSite X EP System Amplifier ENSITE-LV-01 EnSite X Ep System EnSite LiveView Dynamic Display Software License ENSITE-PRSFRNT-01 EnSite X EP System Patient Reference Sensor ENSITE-TF-02 EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled Software License ENSITE-R-AMP-02 EnSite X EP System Amplifier ENSITE-SW-2.1 EnSite X EP System Software Upgrade ENSITE-FWV-01 EnSite X EP System EnSite PFA Catheter Visualization, Software License ENSITE-SRFLNK-01 EnSite X EP System SurfaceLink Module ENSITE-AM-2 EnSite X EP System Advanced Mapping Software License ENSITE-SW-1.2 EnSite X EP System Software Upgrade ENSITE-RAILMNT-01 EnSite X EP System Bedrail Mount ENSITE-PRSBACK-01 EnSite X EP System Patient Reference Sensor ENSITE-LS-01 EnSite X EP System, LiveSync, Software License ENSITE-AMPCART1-01 EnSite X EP System Amplifier Cart ENSITE-SYSTEM-111 EnSite X EP System ENSITE-WM56-60-01 EnSite X EP System IC Output Cable ENSITE-D-AM-2 EnSite X EP System Advanced Mapping Demo Software License ENSITE-D-CF-01 EnSite X EP System Contact Force Software License ENSITE-CIM-80-01 EnSite X EP System Catheter Input Module ENSITE-CIM-20-01 EnSite X EP System Catheter Input Module ENSITE-OTEXPORT-01 EnSite X EP System EnSite Omnipolar Technology Data Export Software License ENSITE-WS-01 EnSite X EP System Wave Speed Map Software License ENSITE-OTAC-03 EnSite X EP System OTA Certificate Software License ENSITE-PFAGEN-01 EnSite X EP System PFA Generator Connect Cable ENSITE-ADASLA-01 ADAS 3D LA License Software License ENSITE-DWS-04 EnSite X EP System Display Workstation ViewFlex Xtra ICE Catheter Safire TX Ablation Catheter Ampere Generator Therapy Dual-8 Ablation Catheter Therapy Ablation Catheter Electrophysiology Cable Ampere Generator Fiber Cord Assembly Remote Ampere Remote Control Ampere Generator Kit Sensor Enabled Diagnostic Connection Cable Reflexion Spiral EP Extension Adaptor EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-5-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-D-CBL Response Electrophysiology Extension Cable Supreme Electrophysiology Cable EnSite X EP System Catheter Connector Cable, D-ENS-INQ-OD-CBL EnSite X EP System Catheter Connector Cable, D-ENS-AVSE-6-CBL Electrophysiology Extension Cable EnSite X EP System Catheter Connector Cable, D-ENS-L/R-HOD-CBL EnSite X EP System Catheter Connector Cable, D-ENS-INQ-Q-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-Q-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-DDY-CBL EnSite X EP System Catheter Connector Cable, D-ENS-L/R-BQ-CBL EnSite X EP System Catheter Connector Cable, D-ENS-INQ-DD-CBL EnSite X EP System Catheter Connector Cable, D-ENS-SUP-H-CBL EnSite X EP System Catheter Connector Cable, D-ENS-L/R-DDY-CBL Electrophysiology Cable EnSite X EP System, Catheter Connector Cable, A-ENS-MAGEXT-CBL Sensor Enabled Cable, Diagnostic Catheter Cable EnSite X EP System Catheter Connector Cable, ICE-VFSE-2D-CBL EnSite X EP System Catheter Connector Cable, D-ENS-AVHDX-CBL Inquiry AFocus II Diagnostic Catheter ViewFlex Xtra ICE Catheter D087031 Inquiry AFocus II Inquiry Inquiry AFocus Inquiry Optima Inquiry AFocus II Inquiry Inquiry AFocus Ampere RF Ablation Generator Ampere Generator Therapy Ablation Catheter Ampere Generator Fiber Cord Assembly Remote Grounding Cable 1710 Electrophysiology Cable Ampere Generator Kit Ampere Remote Control Inquiry Inquiry Optima PLUS Inquiry Optima Inquiry Afocus Inquiry AFocus II IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System Inquiry Steerable Diagnostic Catheter Therapy Ablation Catheter Electrophysiology Cable Safire Catheter Extension Cable Inquiry Inquiry Luma-Cath ViewFlex Xtra ICE Catheter ViewFlex X ICE Catheter, Sensor Enabled Inquiry Luma-Cath Fixed Curve Diagnostic Catheter Inquiry Luma-Cath Steerable Diagnostic Catheter Inquiry Fixed Curve Diagnostic Catheter Inquiry Cardioversion Fixed Curve Diagnostic Catheter Inquiry Optima Diagnostic Catheter Inquiry AFocus II Diagnostic Catheter Inquiry Steerable Diagnostic Catheter Response Electrophysiology Catheter Supreme Electrophysiology Catheter Ampere Generator Cool Point Irrigation Pump Cool Point Tubing Set Ampere Generator Fiber Cord Assembly Remote Ampere Remote Control Ampere Generator Kit Cool Point Irrigation Pump Pressure Alarm Adapter Cable Electrophysiology Cable 1779 Ampere Generator FlexAbility Ablation Catheter Sensor Enabled Ablation Connection Cable Therapy Cool Flex Ablation Catheter FlexAbility Ablation Catheter, Sensor Enabled Therapy Cool Path Duo Ablation Catheter Safire BLU Duo Ablation Catheter IBI 1500T9-CP V1.6 Cardiac Ablation Generator Ampere Generator Accessories Ampere Generator Fiber Cord Assembly Remote Ampere Generator Kit Ampere Remote Control Ampere Footswitch Electrophysiology Cable Cardioverter Cable Response Electrophysiology Extension Cable

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2020-03-24
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2024-08-12
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2014-11-21
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2007-12-07
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2008-02-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-12-21
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2023-01-05
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-02-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-02-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-08-28
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2020-03-24
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-07
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-09-04
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2020-03-24
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-02-13
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2008-02-13
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2012-02-06
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2012-02-06
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2020-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

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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3010273872	Synergy Health AST, SRL	Alajuela, CR
2184149	St. Jude Medical, Atrial Fibrillation Division, Inc.	Saint Paul, MN, US
3000279201	Creation Technologies Ltd	Burnaby British Columbia, CA
9673241	BIOSENSE WEBSTER, INC.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030404. Last updated year: 2026. Please use registration number 2030404 when referencing this establishment in official correspondence.