St Jude Medical
FDA 510(k) medical device clearances.
Top product codes for St Jude Medical
Recent clearances by St Jude Medical
1–100 of 105- K181382 — GuardianTM Burr Hole Cover System
- K172396 — EnSite Velocity Cardiac Mapping System v5.2
- K173232 — myMerlin(TM) Mobile Application Model APP1001
- K160210 — EnSite Precision Cardiac Mapping System v2.0
- K160218 — AutoMark Module
- K160335 — 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
- K162643 — MediGuide Technology System
- K161873 — Pacel Flow Directed Pacing Catheter
- K160187 — Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
- K160186 — EnSite Velocity Surface Electrode Kit
- K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
- K151911 — WorkMate Claris System, WorkMate Claris System Display Plus
- K152784 — Pacel Bipolar Pacing Catheters
- K151622 — 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 Electrophysiology Catheter
- K150631 — St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
- K142235 — CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter
- K142239 — CPS Direct MediGuide Enabled outer catheter
- K142254 — CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
- K141050 — ENSITE VELOCITY SYSTEM
- K140272 — SWIFT-LOCK ANCHOR
- K140327 — ULTIMUM EV HEMOSTASIS INTRODUCER
- K132073 — EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
- K130727 — ENSITE VELOCITY SYSTEM
- K131063 — AMPLATZER TORQ VUE LP DELIVERY SYSTEM
- K130545 — MULTI LEAD TRIAL CABLE
- K130594 — ENSITE VELOCITY SYSTEM
- K130252 — CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
- K130257 — CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
- K122587 — BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
- K122161 — SJM CONFIRM
- K121381 — VIEWFLEX XTRA ICE CATHETER
- K121006 — ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
- K113611 — RAPID PROGRAMMER
- K120544 — RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
- K113584 — PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
- K113773 — ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
- K112688 — ENSITE VELOCITY SYSTEM V.3.0
- K110609 — EPIDUCER LEAD DELIVERY SYSTEM
- K111092 — ENGAGE/ENGAGE TR INTRODUCERS
- K110450 — AGILIS NXT STEERABLE INTRODUCER
- K110549 — ENSITE VELOCITY SYSTEM
- K103083 — AGILIS ES STEERABLE INTRODUCER
- K110085 — VANTAGE VIEW SYSTEM
- K102721 — LIVEWIRE ELECTOPHYSIOLOGY CATHETER
- K101955 — ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
- K101697 — ENSITE VERISMO SEGMENTATION TOOL V.2.0
- K101968 — SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
- K101883 — 6F ENGAGE/ENGAGE TR INTRODUCER
- K101623 — INQUIRY AFOCUSII DIAGNOSTIC CATHETER
- K101328 — ENSITE VELOCITY SYSTEM
- K101667 — ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
- K101419 — ENSITE VELOCITY SYSTEM, MODEL EE3000
- K101239 — VIEWFLEX PLUS ICE CATHETER
- K100710 — ROLL-X GUIDEWIRE
- K093942 — ENSITE VELOCITY SYSTEM V1.3
- K093583 — EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
- K093130 — ENGAGE TR INTRODUCER
- K092876 — SJM ATTUNE ANNULOPLASTY RING
- K092810 — EP-WORKMATE SYSTEM, VERSION 4.2
- K092575 — ENGAGE/ENGAGE TR
- K092310 — SEGUIN ANNULOPLASTY RING
- K083328 — ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
- K081803 — ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
- K091137 — ULTIMUM/ENGAGE/ENGAGE TR
- K090163 — STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
- K083835 — ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
- K080179 — REFLEXION HD HIGH-DENSITY MAPPING CATHETER
- K083402 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
- K082932 — CPS AIM SL SLITTABLE INNER CATHETER
- K081645 — AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
- K083083 — AGILIS NXT STEERABLE INTRODUCER
- K082279 — EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
- K082467 — ENSITE FUSION DYNAMIC REGISTRATION TOOL
- K082304 — ROLL-X GUIDEWIRE
- K081365 — SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
- K080292 — EPICOR ABLATION SYSTEM
- K073563 — MODIFICATION TO PROXIS SYSTEM
- K071818 — ENSITE FUSION DYNAMIC REGISTRATION TOOL
- K072278 — BRK TRANSSEPTAL NEEDLE
- K072012 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER
- K070417 — ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
- K063638 — MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
- K070902 — MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
- K070166 — STRADA CAROTID GUIDING SHEATH
- K062251 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
- K060651 — PROXIS SYSTEM, MODEL EPS101
- K061015 — FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
- K061843 — VENTURE WIRE CONTROL CATHETER, MODEL WCC
- K061710 — CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
- K061363 — AGILIS NXT STEERABLE INTRODUCER
- K053217 — CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
- K053277 — CPS DIRECT SL OUTER CATHETER
- K052575 — LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
- K052644 — SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
- K051840 — ENSITE VERISMO SOFTWARE
- K040165 — REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
- K031906 — APEEL CS CATHETER DELIVERY SYSTEM
- K023447 — MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
- K022380 — LIVESIRE ELECTROPHYSIOLOGY CATHETER
- K020890 — SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.