FDA Registration
Active
🇺🇸 United States
St. Jude Medical, Atrial Fibrillation Division, Inc.
Reg #: 2182269
·
FEI: 2182269
·
Expires 2026
Products
24
Proprietary Names
132
Establishment Types
6
Classifications
24
Registration Details
- Registration Name
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Registration Number
- 2182269
- FEI Number
- 2182269
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 14901 DEVEAU PL.
- City
- Minnetonka
- State
- MN
- ZIP
- 55345
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222217
- PMA Number
- P110016
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-12-04 |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | Class 2 | Cardiovascular | No | 2023-01-11 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2009-08-20 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2015-12-03 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2015-12-03 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2020-03-24 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2012-02-06 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2012-02-06 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2014-05-29 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2012-05-18 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Device, Biopsy, Endomyocardial | DWZ | Class 2 | Cardiovascular | No | 2015-05-04 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2020-03-24 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2025-03-04 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2021-01-11 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2008-12-05 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2007-12-11 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2006-05-22 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2007-12-11 |
| Aortic Valve, Prosthesis, Percutaneously Delivered | NPT | Class 3 | Unknown | No | 2013-02-26 |
| Unit, Cautery, Thermal, Battery-Powered | HQP | Class 2 | Ophthalmic | No | 2015-01-02 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2025-07-01 |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | Class 2 | Cardiovascular | No | 2025-07-01 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1992-08-17 |
Proprietary Names
Cables
ViewFlex Eco Reprocessed ICE Catheter D087031-R
Agilis NxT Steerable Introducer
SMK Radiofrequency Needle
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
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
Engage/Engage TR Introducer
Ultimum Hemostasis Introducer
GuiderRight Guidewires
ThermiRF Accessories
Classic Radiofrequency Cannula
Abbott Medical Grounding Pad
RF Grounding Pad (model RF-DGP-IZ)
Engage Introducer
Engage TR Introducer
MitraClip G5 Steerable Guide Catheter
CPS Direct PL
CPS Direct PL VBT
Renal Guide Catheter
MitraClip Steerable Guide Catheter
TriClip G5 Steerable Guide Catheter
MitraClip G4 Steerable Guide Catheter
TriClip Steerable Guide Catheter
Procure Endomyocardial Biopsy Forceps
TigerWire GuideWires
GuideRight Guidewires
Livewire Steerable Electrophysiology Catheter
MediGuide Enabled Livewire Steerable Electrophysiology Catheter
FastCath Hemostasis Introducer
Electrophysiology Cable
Cardioverter Cable
Response Electrophysiology Extension Cable
ViewFlex Eco Reprocessed ICE catheter
PFA-GEN-OVERLAY-F Current PFA Overlay
A-VOLT-01 Volt PFA Catheter, Sensor Enabled
PFA-TSQ-CBL Current PFA TactiSys Connect Cable
TactiFlex Duo Sensor Enabled Ablation Catheter
PFA-AMP-RETURN-CBL Current PFA Ampere Return Electrode Cable
PFA-GEN-OVERLAY Current PFA Overlay
PFA-GEN-V110 Current PFA Generator Software Upgrade
Safire Bi-Directional Catheter
Livewire TC Ablation Catheter
Safire Catheter Extension Cable
BRK XS Series Transseptal Needle G407211
BRK XS Series Transseptal Needle G407208
BRK-1 XS Series Transseptal Needle G407209
BRK-1 Transseptal Needle 407201
BRK XS Series Transseptal Needle G407210
BRK Transseptal Needle 407205
BRK-1 XS Series Transseptal Needle G407212
BRK-1 XS Series Transseptal Needle G407216
BRK Transseptal Needle 407206
BRK Transseptal Needle 407200
BRK-1 Transseptal Needle 407207
BRK Transseptal Needle G407215
Pacel
Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer
Agilis NxT Steerable Introducer
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
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
Livewire Steerable Electrophysiology Catheter
SJM Vessel Dilator
Agilis NxT, Steerable Introducer
Disposable Electrodes
ANGIO-SEAL HEMOSTATIC
The Nanostim Introducer Kit
Disposable Patient Cables
SJM Adapter
Cable Connectors
SJM Patient Cable 401758,401759,401760
SJM Threshold Cable 401748
SJM Epicardial Cable 401777, 401778
Abbott Medical Threshold Cable
Abbott Medical Epicardial Cable
Abbott Medical Patient Cable
SJM Threshold Cable
SJM Patient Cable
Response with Lumen
Therapy Ablation Catheter
Peel-Awy
Nanostim Introducer Kit
Agilis NxT Introducer
Advisor HD Grid Sensor Enabled, High Density Mapping Catheter
ViewFlex Eco, Reprocessed ICE Catheter
Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer
Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter
ViewFlex Xtra, ICE Catheter
Response Electrophysiology Catheter
Epicardial Catheter System
Response Electrophysiology Catheter with Lumen
Pacel Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773
REPOSITIONING SLEEVE
Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764
Sheath Obturator
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Reprocess Single-Use Device
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility