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
76-96 of 96
Cleared Apr 06, 2007
STRADA CAROTID GUIDING SHEATH
K070166 · DYB
Cardiovascular · 78d
Cleared Oct 20, 2006
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
K062251 · DRF
Cardiovascular · 78d
Cleared Sep 13, 2006
PROXIS SYSTEM, MODEL EPS101
K060651 · NFA
Cardiovascular · 184d
Cleared Aug 03, 2006
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
K061015 · DYB
Cardiovascular · 112d
Cleared Aug 01, 2006
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K061843 · DQY
Cardiovascular · 32d
Cleared Jul 14, 2006
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER
K061710 · DQY
Cardiovascular · 25d
Cleared Jul 12, 2006
AGILIS NXT STEERABLE INTRODUCER
K061363 · DYB
Cardiovascular · 57d
Cleared Mar 08, 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145,...
K053217 · DQY
Cardiovascular · 111d
Cleared Feb 24, 2006
CPS DIRECT SL OUTER CATHETER
K053277 · DQY
Cardiovascular · 93d
Cleared Jan 19, 2006
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · DRA
Cardiovascular · 122d
Cleared Dec 05, 2005
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · DYB
Cardiovascular · 70d
Cleared May 12, 2004
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL...
K040165 · DRA
Cardiovascular · 107d
Cleared Jul 18, 2003
APEEL CS CATHETER DELIVERY SYSTEM
K031906 · DYB
Cardiovascular · 28d
Cleared Oct 31, 2002
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
K023447 · DYB
Cardiovascular · 16d
Cleared Oct 01, 2002
LIVESIRE ELECTROPHYSIOLOGY CATHETER
K022380 · DRF
Cardiovascular · 71d
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890 · DQO
Cardiovascular · 29d
Cleared Oct 09, 2001
SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
K013029 · DYB
Cardiovascular · 29d
Cleared Sep 25, 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · DYB
Cardiovascular · 25d
Cleared Jul 03, 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · DRF
Cardiovascular · 26d
Cleared Jan 03, 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER...
K003729 · DYB
Cardiovascular · 30d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER,...
K002976 · DRF
Cardiovascular · 88d

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