Medical Device Manufacturer · US , Minnetonka , MN

St Jude Medical - FDA 510(k) Cleared Devices

105 submissions · 105 cleared · Since 2000
105
Total
105
Cleared
0
Denied
105 devices
51-75 of 105
Cleared Jul 02, 2010
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL...
K101667 · DQK
Cardiovascular · 18d
Cleared Jun 11, 2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
K101419 · DQK
Cardiovascular · 22d
Cleared Jun 02, 2010
VIEWFLEX PLUS ICE CATHETER
K101239 · DQO
Cardiovascular · 30d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
Cardiovascular · 47d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
Cardiovascular · 65d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
Cardiovascular · 26d
Cleared Nov 04, 2009
ENGAGE TR INTRODUCER
K093130 · DYB
Cardiovascular · 30d
Cleared Oct 16, 2009
SJM ATTUNE ANNULOPLASTY RING
K092876 · KRH
Cardiovascular · 28d
Cleared Oct 09, 2009
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · DQK
Cardiovascular · 28d
Cleared Oct 08, 2009
ENGAGE/ENGAGE TR
K092575 · DYB
Cardiovascular · 48d
Cleared Aug 27, 2009
SEGUIN ANNULOPLASTY RING
K092310 · KRH
Cardiovascular · 29d
Cleared May 22, 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · DQK
Cardiovascular · 191d
Cleared May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
K081803 · DRF
Cardiovascular · 321d
Cleared Apr 22, 2009
ULTIMUM/ENGAGE/ENGAGE TR
K091137 · DYB
Cardiovascular · 2d
Cleared Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · DRB
Cardiovascular · 69d
Cleared Jan 23, 2009
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR
K083835 · KRH
Cardiovascular · 31d
Cleared Jan 07, 2009
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
K080179 · DRF
Cardiovascular · 349d
Cleared Dec 15, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
K083402 · DYB
Cardiovascular · 27d
Cleared Dec 12, 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932 · DQY
Cardiovascular · 72d
Cleared Dec 09, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
K081645 · DYB
Cardiovascular · 180d
Cleared Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · DYB
Cardiovascular · 21d
Cleared Sep 16, 2008
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
K082279 · OCL
Cardiovascular · 36d
Cleared Sep 11, 2008
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K082467 · DQK
Cardiovascular · 15d
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304 · DQX
Cardiovascular · 14d
Cleared Aug 15, 2008
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A...
K081365 · MXC
Cardiovascular · 92d

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