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Data / Medical devices / United States / St. Jude Medical

St. Jude Medical: FDA-registered device maker in Roseville, MN, United States, 76 510(k) clearances and 17 PMA approvals

St. Jude Medical is registered with the FDA (registration 3012179728) in Roseville, MN, United States. It lists 32 device types. The FDA files 76 510(k) clearances and 17 PMA approvals under its listings, the newest dated July 2, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch St. Jude Medical
FDA registration number
3012179728
Address
2305 Walnut Street, Roseville, MN, United States, 55113
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Manufacturer, Manufacturer for export
First device listed
October 16, 2007
Registered through
2027
Brand names listed
2-port DVI splitter, 4 Outlet Reverse IEC Accessory Power Str, AMPLATZER Sizing Balloon, AMPLATZER Vascular Plug - II ES, AMPLATZER Vascular Plug 4, Abbott Medical Epicardial Cable, Abbott Medical Patient Cable, Abbott Medical Threshold Cable and more

Devices it lists

DeviceProduct codeClassRoleSource
Aortic Valve, Prosthesis, Percutaneously DeliveredNPT3Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufactureraccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufactureraccessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density ArrayMTD2Manufactureraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Manufactureraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Catheter, SteerableDRA2Manufactureraccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Manufactureraccessdata.fda.gov
Clamp, VascularDXC2Manufactureraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Manufactureraccessdata.fda.gov
Electrode, Pacemaker, TemporaryLDF2Manufactureraccessdata.fda.gov
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)JOQ2Manufactureraccessdata.fda.gov
Heart-Valve, MechanicalLWQ3Manufactureraccessdata.fda.gov
Heart-Valve, Non-Allograft TissueLWR3Manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Occluder, Patent Ductus, ArteriosusMAE3Manufactureraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Mitral Valve, Percutaneously DeliveredNPU3Manufactureraccessdata.fda.gov
Replacement Heart-ValveDYE3Manufactureraccessdata.fda.gov
Reprocessed Intravascular Ultrasound CatheterOWQ2Manufactureraccessdata.fda.gov
Ring, AnnuloplastyKRH2Manufactureraccessdata.fda.gov
System, Appendage Closure, Left AtrialNGV3Manufactureraccessdata.fda.gov
System, Imaging, Optical Coherence Tomography (Oct)NQQ2Manufactureraccessdata.fda.gov
System, Signal IsolationDRJ1Manufactureraccessdata.fda.gov
Transcatheter Septal OccluderMLV3Manufactureraccessdata.fda.gov
TrocarDRC2Manufactureraccessdata.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
July 2, 2026K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQYSubstantially EquivalentAbbottaccessdata.fda.gov
June 17, 2026K261631Amplatzer TorqVue Exchange SystemDQYSubstantially EquivalentAbbott Medicalaccessdata.fda.gov
April 24, 2026K260993Amplatzer TorqVue Delivery SystemDQYSubstantially EquivalentAbbottaccessdata.fda.gov
March 13, 2026K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80DQYSubstantially 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
May 23, 2025K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™OBJSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
May 20, 2025K251231ViewFlex™ X ICE Catheter, Sensor Enabled™OBJSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
April 25, 2025K250426Amulet™ Steerable Delivery SheathDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 13, 2024K243493Agilis NxT Steerable Introducer Dual-ReachDYBSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 9, 2024K242016EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
July 9, 2024K241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™MTDSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
June 13, 2024K241370Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)DYBSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
September 29, 2023K232690Amulet™ Steerable Delivery SheathDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
August 10, 2023K231415EnSite™ X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
December 7, 2022K223077ViewFlex Xtra ICE CatheterOBJSubstantially EquivalentIrvine Biomedical, A St. Jude Medical Companyaccessdata.fda.gov
November 11, 2021K213364EnSite X EP SystemDQKSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
October 22, 2021K212061EnSite X EP SystemDQKSubstantially EquivalentAbbottaccessdata.fda.gov
September 27, 2021K212738Amplatzer Talisman Delivery SheathDQYSubstantially EquivalentABBOTT MEDICALaccessdata.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
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
September 17, 2019K192037Advisor VL Circular Mapping Catheter, Sensor EnabledDRFSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
April 5, 2019K190581Amplatzer Trevisio Intravascular Delivery SystemDQYSubstantially EquivalentABBOTT MEDICALaccessdata.fda.gov
April 23, 2018K172393Advisor HD Grid Mapping Catheter, Sensor EnabledMTDSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
December 23, 2016K163000AMPLATZER TorqVue 45x45 Delivery SheathDQYSubstantially EquivalentAga Medical COrporation (Wholly Owned by St. Jude Medical COaccessdata.fda.gov
December 13, 2016K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi DDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
September 9, 2016K162228TorqVue Low Profile Delivery CatheterDQYSubstantially EquivalentAga Medical Corporation (Wholly Owned by St.Jude Medical Coraccessdata.fda.gov
July 15, 2015K151622St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology CatheterDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
April 1, 2015K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology CatheterDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
August 18, 2014K141769OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETERDQOSubstantially EquivalentLightlab Imaging, Inc.accessdata.fda.gov
August 15, 2013K131063AMPLATZER TORQ VUE LP DELIVERY SYSTEMDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
March 20, 2013K130257CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETERDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
March 20, 2013K130252CPS AIM UNIVERSAL SLITTABLE INNER CATHETERDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
June 12, 2012K113658AMPLATZER VASCULAR PLUG 4KRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
August 10, 2011K111201C7 XR IMAGING SYSTEMNQQSubstantially EquivalentLightlab Imaging, Inc.accessdata.fda.gov
May 10, 2011K110450AGILIS NXT STEERABLE INTRODUCERDYBSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
February 24, 2011K110193FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; FDXCSubstantially EquivalentSt. Jude Medical Systems ABaccessdata.fda.gov
January 19, 2011K103250CPS DIRECT SL II SLITTABLE OUTER CATHETERDQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
August 13, 2010K101623INQUIRY AFOCUSII DIAGNOSTIC CATHETERDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
February 5, 2010K093476AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120DQYSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
October 16, 2009K092913EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04JOQSubstantially EquivalentEp Medsystemsaccessdata.fda.gov
August 27, 2009K092310SEGUIN ANNULOPLASTY RINGKRHSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
August 7, 2009K092075CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005DQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
July 1, 2009K090613CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2DQYSubstantially EquivalentSt. Jude Medical, Cardiac Rhythm Management Divisiaccessdata.fda.gov
December 12, 2008K082932CPS AIM SL SLITTABLE INNER CATHETERDQYSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
December 9, 2008K081645AGILIS NXT STEERABLE INTRODUCER, MODEL G408324DYBSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
May 16, 2008K080994AMPLATZER TORQVUE EXCHANGE SYSTEMDQYSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
November 2, 2007K072313AMPLATZER TORQVUE DELIVERY SYSTEMDQYSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
August 22, 2007K072012REFLEXION SPIRAL VARIABLE RADIUS CATHETERDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
August 15, 2007K071699AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022KRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
June 18, 2007K071125AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016KRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
August 3, 2006K061015FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCERDYBSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
July 12, 2006K061363AGILIS NXT STEERABLE INTRODUCERDYBSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
December 30, 2005K053440AMPLATZER SIZING BALLOON IIMJNSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
December 5, 2005K052644SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCERDYBSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
December 17, 2004K042734SJM RIGID SADDLE RING MODEL RSAR-(SIZE)KRHSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
November 4, 2004K042775INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETERDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
September 9, 2003K031810AMPLATZER VASCULAR PLUGKRDSubstantially EquivalentAga Medical Corp.accessdata.fda.gov
October 1, 2002K022380LIVESIRE ELECTROPHYSIOLOGY CATHETERDRFSubstantially EquivalentSt Jude Medicalaccessdata.fda.gov
September 19, 2002K022363SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)KRHSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
January 15, 2002K014161SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)KRHSubstantially EquivalentSt. Jude Medical, Inc.accessdata.fda.gov
July 25, 1998K982232MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
May 21, 1998K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERDYBSubstantially EquivalentDaig Corp.accessdata.fda.gov
May 14, 1997K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDYBSubstantially EquivalentDaig Corp.accessdata.fda.gov
April 11, 1997K961924IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
November 28, 1995K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDYBSubstantially EquivalentDaig Corp.accessdata.fda.gov
July 18, 1995K946333IBI-1000(TM) ELECTROPHYSIOLOGY CATHTERDRFSubstantially EquivalentIrvine Biomedical, Inc.accessdata.fda.gov
January 26, 1993K913940RESPONSE(TM) STEERABLE CATHETERDRASubstantially EquivalentDaig Corp.accessdata.fda.gov
January 27, 1992K914185PACEL(TM) FLOW DIRECTED PACING CATHETERLDFSubstantially EquivalentDaig Corp.accessdata.fda.gov
May 7, 1991K910645DISPOSABLE PATIENT CABLEDSASubstantially EquivalentDiag Corp.accessdata.fda.gov
September 26, 1989K894343DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMODYBSubstantially EquivalentDaig Corp.accessdata.fda.gov
September 18, 1989K894500DAIG ELECTROPHYSIOLOGY CATHETERDRFSubstantially EquivalentDaig Corp.accessdata.fda.gov
February 12, 1988K875059DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODELDFSubstantially EquivalentDaig Corp.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 23, 2025P240042Tendyne Transcatheter Mitral Valve SystemNPU4August 31, 2026accessdata.fda.gov
May 18, 2023P220013TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency COAE32September 22, 2026accessdata.fda.gov
September 17, 2021P190023Portico Transcatheter Aortic Valve Implantation SystemNPT32July 9, 2026accessdata.fda.gov
August 14, 2021P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV19August 28, 2026accessdata.fda.gov
October 28, 2016P120021AMPLATZER PFO OCCLUDERMLV26May 28, 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
September 7, 2007P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV47May 28, 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
August 5, 2005P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR60September 18, 2026accessdata.fda.gov
January 14, 2005P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATORLPB50September 3, 2026accessdata.fda.gov
May 14, 2003P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE65May 28, 2026accessdata.fda.gov
December 5, 2001P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV76May 28, 2026accessdata.fda.gov
May 4, 1999P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEMLPB89August 7, 2026accessdata.fda.gov
December 17, 1982P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ119June 11, 2026accessdata.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.