Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2182269

FEI Number

2182269

Entity Name

St. Jude Medical, Atrial Fibrillation Division, Inc.

City/State/Country

Minnetonka, MN, US

Establishment Address

14901 DEVEAU PL., Minnetonka, MN 55345, US

Establishment Type(s)

Manufacture Medical Device

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

K111092

PMA Number

N/A

All Registered 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) Response Electrophysiology Catheter Supreme Electrophysiology Catheter 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 ViewFlex Eco Reprocessed ICE Catheter D087031-R 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 Ampere Generator Livewire TC Ablation Catheter Ampere Generator Kit Ampere Generator Fiber Cord Assembly Remote Safire Catheter Extension Cable Ampere Remote Control 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 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 Livewire Steerable Electrophysiology Catheter SJM Vessel Dilator Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer 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 Abbott Medical Patient Cable Abbott Medical Threshold Cable Response with Lumen Therapy Ablation Catheter Electrophysiology Cable Safire Catheter Extension Cable Engage Introducer Engage TR Introducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-04
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-01-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-08-20
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2015-12-03
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-03
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2020-03-24
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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-07-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-08-16
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-07-06
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-05-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-04-18
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-04
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2022-01-24
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2007-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2009-07-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-05-18
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2007-12-11
DWZ	Device, Biopsy, Endomyocardial	Cardiovascular	Class 2	870.4075	2015-05-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-07-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-05-29
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-05-04
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2015-07-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-07-20
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2020-03-24
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2023-07-18
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2015-07-06
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2025-03-04
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2007-12-11
DRC	Trocar	Cardiovascular	Class 2	870.1390	2021-01-11
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-12-05
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-08-02
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	2010-11-08
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-12-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-05-27
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-02-26
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2006-05-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-01-27
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-12-11
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2008-12-05
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2013-02-26
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2009-08-20
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2015-01-02
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2020-03-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-08-16

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
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2182269. Last updated year: 2026. Please use registration number 2182269 when referencing this establishment in official correspondence.