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
26-50 of 105
Cleared May 03, 2013
ENSITE VELOCITY SYSTEM
K130594 · DQK
Cardiovascular · 57d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · DQY
Cardiovascular · 47d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · DQY
Cardiovascular · 47d
Cleared Feb 07, 2013
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
K122587 · DRC
Cardiovascular · 167d
Cleared Nov 28, 2012
SJM CONFIRM
K122161 · MXC
Cardiovascular · 131d
Cleared Jun 07, 2012
VIEWFLEX XTRA ICE CATHETER
K121381 · IYO
Radiology · 30d
Cleared May 03, 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · MTD
Cardiovascular · 30d
Cleared Apr 20, 2012
RAPID PROGRAMMER
K113611 · GZB
Neurology · 136d
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 24, 2011
EPIDUCER LEAD DELIVERY SYSTEM
K110609 · LHG
Neurology · 113d
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 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697 · LLZ
Radiology · 98d
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

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