Medical Device Manufacturer · US , Minnetonka , MN

St Jude Medical - FDA 510(k) Cleared Devices

105 submissions · 105 cleared · Since 2000

Official Website

105

Total

105

Cleared

0

Denied

105 devices

76-100 of 105

Cleared Jul 25, 2008

EPICOR ABLATION SYSTEM

Cardiovascular · 172d

Cleared Jan 31, 2008

MODIFICATION TO PROXIS SYSTEM

Cardiovascular · 43d

Cleared Dec 20, 2007

ENSITE FUSION DYNAMIC REGISTRATION TOOL

Cardiovascular · 170d

Cleared Sep 13, 2007

BRK TRANSSEPTAL NEEDLE

Cardiovascular · 28d

Cleared Aug 22, 2007

REFLEXION SPIRAL VARIABLE RADIUS CATHETER

Cardiovascular · 30d

Cleared Jun 05, 2007

ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981,...

Cardiovascular · 113d

Cleared May 11, 2007

MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101

Cardiovascular · 155d

Cleared May 01, 2007

MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

Cardiovascular · 29d

Cleared Apr 06, 2007

STRADA CAROTID GUIDING SHEATH

Cardiovascular · 78d

Cleared Oct 20, 2006

REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804

Cardiovascular · 78d

Cleared Sep 13, 2006

PROXIS SYSTEM, MODEL EPS101

Cardiovascular · 184d

Cleared Aug 03, 2006

FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER

Cardiovascular · 112d

Cleared Aug 01, 2006

VENTURE WIRE CONTROL CATHETER, MODEL WCC

Cardiovascular · 32d

Cleared Jul 14, 2006

CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER

Cardiovascular · 25d

Cleared Jul 12, 2006

AGILIS NXT STEERABLE INTRODUCER

Cardiovascular · 57d

Cleared Mar 08, 2006

CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145,...

Cardiovascular · 111d

Cleared Feb 24, 2006

CPS DIRECT SL OUTER CATHETER

Cardiovascular · 93d

Cleared Jan 19, 2006

LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN

Cardiovascular · 122d

Cleared Dec 05, 2005

SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER

Cardiovascular · 70d

Cleared Aug 15, 2005

ENSITE VERISMO SOFTWARE

Radiology · 39d

Cleared May 12, 2004

REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL...

Cardiovascular · 107d

Cleared Jul 18, 2003

APEEL CS CATHETER DELIVERY SYSTEM

Cardiovascular · 28d

Cleared Oct 31, 2002

MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)

Cardiovascular · 16d

Cleared Oct 01, 2002

LIVESIRE ELECTROPHYSIOLOGY CATHETER

Cardiovascular · 71d

Cleared Apr 17, 2002

SPYGLASS 4 FR ANGIOGRAPHICY CATHETER

Cardiovascular · 29d

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