FDA Registration
Active
🇺🇸 United States
IRVINE BIOMEDICAL. INC.
Reg #: 2030404
·
FEI: 1000519796
·
Expires 2026
Products
9
Proprietary Names
192
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- IRVINE BIOMEDICAL. INC.
- Registration Number
- 2030404
- FEI Number
- 1000519796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2375 Morse Ave
- City
- IRVINE
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242016
- PMA Number
- P040042
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2020-03-24 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2024-08-12 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2014-11-21 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2008-02-13 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2007-12-07 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2008-02-13 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-07-01 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2025-07-01 |
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
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
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
Ampere RF Ablation Generator
Therapy Ablation Catheter
Grounding Cable 1710
Inquiry Optima PLUS
Inquiry Afocus
IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System
Inquiry Steerable Diagnostic Catheter
Safire Catheter Extension Cable
Inquiry Luma-Cath
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
Cool Point Irrigation Pump
Cool Point Tubing Set
Cool Point Irrigation Pump Pressure Alarm Adapter Cable
Electrophysiology Cable 1779
FlexAbility Ablation Catheter
Sensor Enabled Ablation Connection Cable
FlexAbility Ablation Catheter, Sensor Enabled
Safire BLU Duo Ablation Catheter
IBI 1500T9-CP V1.6 Cardiac Ablation Generator
Ampere Generator Accessories
Ampere Footswitch
Cardioverter Cable
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
Agilis NxT, Steerable Introducer
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
ViewFlex Xtra, ICE Catheter
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility