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Data / Medical devices / United States / St. Jude Medical, Atrial Fibrillation Division, Inc.

St. Jude Medical, Atrial Fibrillation Division, Inc.: FDA-registered device maker in Saint Paul, MN, United States, 36 510(k) clearances and 8 PMA approvals

St. Jude Medical, Atrial Fibrillation Division, Inc. is registered with the FDA (registration 2184149) in Saint Paul, MN, United States. It lists 17 device types. The FDA files 36 510(k) clearances and 8 PMA approvals under its listings, the newest dated September 17, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch St. Jude Medical, Atrial Fibrillation Division, Inc.
FDA registration number
2184149
FEI number
1000139754
Address
One St. Jude Medical Drive, Saint Paul, MN, United States, 55117
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
December 7, 2007
Registered through
2027
Brand names listed
2-port DVI splitter, 4 Outlet Reverse IEC Accessory Power Str, AO USB Receiver, Additional Monitor Stand Kit, Advisor FL Mapping Catheter, Sensor Enabled Software Installation, Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507, Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519 and more

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Specification developeraccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Manufacturer, Specification developeraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufactureraccessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density ArrayMTD2Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Manufacturer, Specification developeraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Manufacturer, Manufacturer for export, Specification developeraccessdata.fda.gov
Computer, Blood-PressureDSK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developeraccessdata.fda.gov
Display, Cathode-Ray Tube, MedicalDXJ2Specification developeraccessdata.fda.gov
Generator, Lesion, RadiofrequencyGXD2Manufactureraccessdata.fda.gov
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)JOQ2Manufacturer, Specification developeraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Manufacturer, Manufacturer for exportaccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufactureraccessdata.fda.gov
System, Signal IsolationDRJ1Manufacturer, Specification developeraccessdata.fda.gov
Transducer, Pressure, Catheter TipDXO2Manufactureraccessdata.fda.gov
Transmitters And Receivers, Physiological Signal, RadiofrequencyDRG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 17, 2026K261729EnSite™ X EP SystemDQKSubstantially EquivalentAbbott Medicalaccessdata.fda.gov
July 15, 2026K262006EnSite™ X EP SystemDQKSubstantially EquivalentAbbott Medicalaccessdata.fda.gov
April 20, 2026K260212EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
September 25, 2025K252013EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
September 4, 2025K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)DQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
July 30, 2025K251234EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 9, 2024K242016EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 10, 2023K231415EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 27, 2022K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software LicenseDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 18, 2022K221213EnSite X EP SystemDQKSubstantially EquivalentAbbottaccessdata.fda.gov
November 11, 2021K213364EnSite X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
October 22, 2021K212061EnSite X EP SystemDQKSubstantially EquivalentAbbottaccessdata.fda.gov
March 11, 2021K210392WorkMate Claris SystemDQKSubstantially EquivalentAbbottaccessdata.fda.gov
November 25, 2020K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor EnabledDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
October 21, 2020K201610IonicRF GeneratorGXDSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
June 26, 2020K201181EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
June 26, 2020K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software LicenseDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
February 28, 2019K183099QUANTIEN Measurement SystemDQKSubstantially EquivalentSt. Jude Medical (Now Abbott Medical)accessdata.fda.gov
December 12, 2018K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQKSubstantially EquivalentAbbottaccessdata.fda.gov
October 19, 2018K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQKSubstantially EquivalentAbbottaccessdata.fda.gov
April 23, 2018K172396EnSite Velocity Cardiac Mapping System v5.2DQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
August 18, 2017K172182QUANTIEN Measurement SystemDQKSubstantially EquivalentSt. Jude Medical (Now Part of the Abbott Medical)accessdata.fda.gov
December 13, 2016K160218AutoMark ModuleDQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
December 13, 2016K160210EnSite Precision Cardiac Mapping System v2.0DQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
June 6, 2014K141050ENSITE VELOCITY SYSTEMDQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
December 20, 2013K133587PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300DRGSubstantially EquivalentSt. Jude Medical Systems ABaccessdata.fda.gov
May 3, 2013K130594ENSITE VELOCITY SYSTEMDQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
March 28, 2013K123984QUANTIEN MEASUREMENT SYSTEMDQKSubstantially EquivalentRadi Medical Systems ABaccessdata.fda.gov
March 2, 2012K113584PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVERDXOSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
November 9, 2011K112688ENSITE VELOCITY SYSTEM V.3.0DQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
October 21, 2011K111854AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVERDRGSubstantially EquivalentSt. Jude Medical Systems ABaccessdata.fda.gov
January 26, 2011K110085VANTAGE VIEW SYSTEMDXJSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
October 16, 2009K092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04JOQSubstantially EquivalentEp Medsystemsaccessdata.fda.gov
October 9, 2009K092810EP-WORKMATE SYSTEM, VERSION 4.2DQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
May 22, 2009K083328ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010DQKSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
January 23, 2006K052878NT-1000GXDSubstantially EquivalentNeuro Therm, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
December 19, 2025P250022Volt™ PFA SystemQZI10October 15, 2026accessdata.fda.gov
May 18, 2023P220013TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency COAE32September 22, 2026accessdata.fda.gov
October 24, 2014P130026TACTICATH QUARTZ SETOAE99August 7, 2026accessdata.fda.gov
January 25, 2012P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD91August 7, 2026accessdata.fda.gov
March 16, 2007P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RFOAD55August 7, 2026accessdata.fda.gov
November 18, 2005P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETEROAD57September 3, 2026accessdata.fda.gov
January 14, 2005P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB50September 3, 2026accessdata.fda.gov
May 4, 1999P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB89August 7, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
December 18, 202393711Class IIOngoingTactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.accessdata.fda.gov
May 5, 202187904Class IITerminatedv.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.accessdata.fda.gov
April 22, 202187826Class IITerminatedNeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.accessdata.fda.gov
April 5, 201982727Class IITerminatedTactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be displayed during the procedure.accessdata.fda.gov

Compare with other makers

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.