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
96 devices
26-50 of 96
Cleared Nov 28, 2012
SJM CONFIRM
K122161 · MXC
Cardiovascular · 131d
Cleared May 03, 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · MTD
Cardiovascular · 30d
Cleared Mar 19, 2012
RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
K120544 · DRF
Cardiovascular · 25d
Cleared Mar 02, 2012
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · DXO
Cardiovascular · 88d
Cleared Jan 18, 2012
ST JUDE MEDICAL, IS4 FLUSHING/FUNNELING TOOL
K113773 · KRA
Cardiovascular · 27d
Cleared Nov 09, 2011
ENSITE VELOCITY SYSTEM V.3.0
K112688 · DQK
Cardiovascular · 55d
Cleared Jun 09, 2011
ENGAGE/ENGAGE TR INTRODUCERS
K111092 · DYB
Cardiovascular · 51d
Cleared May 10, 2011
AGILIS NXT STEERABLE INTRODUCER
K110450 · DYB
Cardiovascular · 83d
Cleared May 05, 2011
ENSITE VELOCITY SYSTEM
K110549 · DQK
Cardiovascular · 69d
Cleared Apr 08, 2011
AGILIS ES STEERABLE INTRODUCER
K103083 · DYB
Cardiovascular · 171d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
Cardiovascular · 15d
Cleared Oct 18, 2010
LIVEWIRE ELECTOPHYSIOLOGY CATHETER
K102721 · DRF
Cardiovascular · 27d
Cleared Oct 15, 2010
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY...
K101955 · DRF
Cardiovascular · 95d
Cleared Sep 15, 2010
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · MXC
Cardiovascular · 65d
Cleared Sep 07, 2010
6F ENGAGE/ENGAGE TR INTRODUCER
K101883 · DYB
Cardiovascular · 63d
Cleared Aug 13, 2010
INQUIRY AFOCUSII DIAGNOSTIC CATHETER
K101623 · DRF
Cardiovascular · 65d
Cleared Jul 14, 2010
ENSITE VELOCITY SYSTEM
K101328 · DQK
Cardiovascular · 64d
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

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