FDA 510(k) Applications Submitted by St. Jude Medical

FDA 510(k) Number Submission Date Device Name Applicant
K061710 06/19/2006 CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS ST. JUDE MEDICAL
K080179 01/24/2008 REFLEXION HD HIGH-DENSITY MAPPING CATHETER ST. JUDE MEDICAL
K081803 06/26/2008 ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM ST. JUDE MEDICAL
K011766 06/07/2001 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027 ST. JUDE MEDICAL
K003729 12/04/2000 ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), ST. JUDE MEDICAL
K161873 07/07/2016 Pacel Flow Directed Pacing Catheter St. Jude Medical
K113584 12/05/2011 PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER ST. JUDE MEDICAL
K130252 02/01/2013 CPS AIM UNIVERSAL SLITTABLE INNER CATHETER ST. JUDE MEDICAL
K130257 02/01/2013 CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER ST. JUDE MEDICAL
K082932 10/01/2008 CPS AIM SL SLITTABLE INNER CATHETER ST. JUDE MEDICAL
K002976 09/25/2000 RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX ST. JUDE MEDICAL
K053217 11/17/2005 CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 ST. JUDE MEDICAL
K053277 11/23/2005 CPS DIRECT SL OUTER CATHETER ST. JUDE MEDICAL
K140272 02/03/2014 SWIFT-LOCK ANCHOR ST. JUDE MEDICAL
K093942 12/22/2009 ENSITE VELOCITY SYSTEM V1.3 ST. JUDE MEDICAL
K110549 02/25/2011 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL
K130594 03/07/2013 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL
K130727 03/18/2013 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL
K141050 04/23/2014 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL
K101328 05/11/2010 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL
K101419 05/20/2010 ENSITE VELOCITY SYSTEM, MODEL EE3000 ST. JUDE MEDICAL
K101667 06/14/2010 ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) ST. JUDE MEDICAL
K082279 08/11/2008 EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 ST. JUDE MEDICAL
K112688 09/15/2011 ENSITE VELOCITY SYSTEM V.3.0 ST. JUDE MEDICAL
K081365 05/15/2008 SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR ST. JUDE MEDICAL
K090163 01/22/2009 STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 ST. JUDE MEDICAL
K142239 08/13/2014 CPS Direct MediGuide Enabled outer catheter St. Jude Medical
K142254 08/14/2014 CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St. Jude Medical
K113773 12/22/2011 ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL ST. JUDE MEDICAL
K040165 01/26/2004 REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 ST. JUDE MEDICAL
K061363 05/16/2006 AGILIS NXT STEERABLE INTRODUCER ST. JUDE MEDICAL
K062251 08/03/2006 REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 ST. JUDE MEDICAL
K052644 09/26/2005 SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER ST. JUDE MEDICAL
K023447 10/15/2002 MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) ST. JUDE MEDICAL
K150631 03/11/2015 St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter St. Jude Medical
K122587 08/24/2012 BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 ST. JUDE MEDICAL
K131063 04/16/2013 AMPLATZER TORQ VUE LP DELIVERY SYSTEM ST. JUDE MEDICAL
K070166 01/18/2007 STRADA CAROTID GUIDING SHEATH ST. JUDE MEDICAL
K082304 08/13/2008 ROLL-X GUIDEWIRE ST. JUDE MEDICAL
K173232 10/04/2017 myMerlin(TM) Mobile Application Model APP1001 St. Jude Medical
K100710 03/12/2010 ROLL-X GUIDEWIRE ST. JUDE MEDICAL
K022380 07/22/2002 LIVESIRE ELECTROPHYSIOLOGY CATHETER ST. JUDE MEDICAL
K013029 09/10/2001 SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515 ST. JUDE MEDICAL
K051840 07/07/2005 ENSITE VERISMO SOFTWARE ST. JUDE MEDICAL
K083328 11/12/2008 ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 ST. JUDE MEDICAL
K080292 02/04/2008 EPICOR ABLATION SYSTEM ST. JUDE MEDICAL
K070902 04/02/2007 MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 ST. JUDE MEDICAL
K071818 07/03/2007 ENSITE FUSION DYNAMIC REGISTRATION TOOL ST. JUDE MEDICAL
K082467 08/27/2008 ENSITE FUSION DYNAMIC REGISTRATION TOOL ST. JUDE MEDICAL
K060651 03/13/2006 PROXIS SYSTEM, MODEL EPS101 ST. JUDE MEDICAL
K020890 03/19/2002 SPYGLASS 4 FR ANGIOGRAPHICY CATHETER ST. JUDE MEDICAL
K012922 08/31/2001 ULTRAFLEX EV HEMOSTASIS INTRODUCER ST. JUDE MEDICAL
K110085 01/11/2011 VANTAGE VIEW SYSTEM ST. JUDE MEDICAL
K101697 06/16/2010 ENSITE VERISMO SEGMENTATION TOOL V.2.0 ST. JUDE MEDICAL
K132073 07/03/2013 EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE ST. JUDE MEDICAL
K130545 03/01/2013 MULTI LEAD TRIAL CABLE ST. JUDE MEDICAL
K070417 02/12/2007 ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 ST. JUDE MEDICAL
K072012 07/23/2007 REFLEXION SPIRAL VARIABLE RADIUS CATHETER ST. JUDE MEDICAL
K072278 08/16/2007 BRK TRANSSEPTAL NEEDLE ST. JUDE MEDICAL
K083083 10/16/2008 AGILIS NXT STEERABLE INTRODUCER ST. JUDE MEDICAL
K103083 10/19/2010 AGILIS ES STEERABLE INTRODUCER ST. JUDE MEDICAL
K091137 04/20/2009 ULTIMUM/ENGAGE/ENGAGE TR ST. JUDE MEDICAL
K092575 08/21/2009 ENGAGE/ENGAGE TR ST. JUDE MEDICAL
K093130 10/05/2009 ENGAGE TR INTRODUCER ST. JUDE MEDICAL
K073563 12/19/2007 MODIFICATION TO PROXIS SYSTEM ST. JUDE MEDICAL
K140327 02/10/2014 ULTIMUM EV HEMOSTASIS INTRODUCER ST. JUDE MEDICAL
K101239 05/03/2010 VIEWFLEX PLUS ICE CATHETER ST. JUDE MEDICAL
K121381 05/08/2012 VIEWFLEX XTRA ICE CATHETER ST. JUDE MEDICAL
K081645 06/12/2008 AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 ST. JUDE MEDICAL
K083402 11/18/2008 AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323 ST. JUDE MEDICAL
K151622 06/16/2015 St.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 Electroph St. Jude Medical
K160210 01/28/2016 EnSite Precision Cardiac Mapping System v2.0 ST. JUDE MEDICAL
K120544 02/23/2012 RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN ST. JUDE MEDICAL
K162643 09/22/2016 MediGuide Technology System ST. JUDE MEDICAL
K160187 01/27/2016 Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 ST. JUDE MEDICAL
K160218 01/29/2016 AutoMark Module St. Jude Medical
K151911 07/13/2015 WorkMate Claris System, WorkMate Claris System Display Plus ST. JUDE MEDICAL
K172396 08/08/2017 EnSite Velocity Cardiac Mapping System v5.2 St. Jude Medical
K031906 06/20/2003 APEEL CS CATHETER DELIVERY SYSTEM ST. JUDE MEDICAL
K102721 09/21/2010 LIVEWIRE ELECTOPHYSIOLOGY CATHETER ST. JUDE MEDICAL
K121006 04/03/2012 ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER ST. JUDE MEDICAL
K152342 08/19/2015 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover ST. JUDE MEDICAL
K152784 09/25/2015 Pacel Bipolar Pacing Catheters ST. JUDE MEDICAL
K052575 09/19/2005 LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN ST. JUDE MEDICAL
K101623 06/09/2010 INQUIRY AFOCUSII DIAGNOSTIC CATHETER ST. JUDE MEDICAL
K110609 03/03/2011 EPIDUCER LEAD DELIVERY SYSTEM ST. JUDE MEDICAL
K122161 07/20/2012 SJM CONFIRM ST. JUDE MEDICAL
K061843 06/30/2006 VENTURE WIRE CONTROL CATHETER, MODEL WCC ST. JUDE MEDICAL
K063638 12/07/2006 MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 ST. JUDE MEDICAL
K101968 07/12/2010 SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A ST. JUDE MEDICAL
K160335 02/08/2016 Advisor 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 D St. Jude Medical
K113611 12/06/2011 RAPID PROGRAMMER ST. JUDE MEDICAL
K092310 07/29/2009 SEGUIN ANNULOPLASTY RING ST. JUDE MEDICAL
K092876 09/18/2009 SJM ATTUNE ANNULOPLASTY RING ST. JUDE MEDICAL
K093583 11/19/2009 EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE ST. JUDE MEDICAL
K092810 09/11/2009 EP-WORKMATE SYSTEM, VERSION 4.2 ST. JUDE MEDICAL
K111092 04/19/2011 ENGAGE/ENGAGE TR INTRODUCERS ST. JUDE MEDICAL
K101883 07/06/2010 6F ENGAGE/ENGAGE TR INTRODUCER ST. JUDE MEDICAL
K110450 02/16/2011 AGILIS NXT STEERABLE INTRODUCER ST. JUDE MEDICAL
K101955 07/12/2010 ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 ST. JUDE MEDICAL
K083835 12/23/2008 ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR ST. JUDE MEDICAL
K160186 01/27/2016 EnSite Velocity Surface Electrode Kit ST. JUDE MEDICAL
K142235 08/13/2014 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter St. Jude Medical


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