Medical Device Manufacturer · US , Salt Lake City , UT

St. Jude Medical, Inc. - FDA 510(k) Cleared Devices

23 submissions · 22 cleared · Since 1989

Official Website

23

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - St. Jude Medical, Inc. Cardiovascular ✕

23 devices

1-23 of 23

Cleared Apr 23, 2018

Advisor HD Grid Mapping Catheter, Sensor Enabled

Cardiovascular · 258d

Cleared Sep 29, 2017

Confirm Rx Insertable Cardiac Monitor (ICM) System

Cardiovascular · 298d

Cleared Aug 15, 2016

PressureWire X Guidewire

Cardiovascular · 111d

Cleared May 19, 2016

Nanostim Introducer Kit

Cardiovascular · 30d

Cleared Apr 14, 2016

The Nanostim Introducer Kit

Cardiovascular · 30d

Cleared Dec 17, 2014

NANOSTIM INTRODUCER KIT

Cardiovascular · 261d

Cleared May 28, 2014

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)

Cardiovascular · 196d

Cleared Jan 31, 2014

ENLIGHTN RENAL GUIDE CATHETER

Cardiovascular · 242d

Cleared Oct 02, 2008

6F PROXIS SYSTEM

Cardiovascular · 276d

Cleared Dec 17, 2004

SJM RIGID SADDLE RING MODEL RSAR-(SIZE)

Cardiovascular · 77d

Cleared Sep 19, 2002

SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)

Cardiovascular · 59d

Cleared Jan 15, 2002

SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)

Cardiovascular · 27d

Cleared Jan 04, 2002

SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)

Cardiovascular · 28d

Cleared May 31, 2000

FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX

Cardiovascular · 30d

Cleared May 24, 2000

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

Cardiovascular · 26d

Cleared Feb 17, 2000

SJM TAILOR ANNULOPLASTY RING, MODEL TARN

Cardiovascular · 30d

Cleared Feb 14, 1997

SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M

Cardiovascular · 319d

Cleared Feb 10, 1995

REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING

Cardiovascular · 472d

Cleared Sep 28, 1994

LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI

Cardiovascular · 464d

Cleared May 21, 1992

LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP

Cardiovascular · 58d

Cleared Jan 18, 1991

BIFLEX(TM) ANNULOPLASTY RING

Cardiovascular · 248d

Cleared Mar 19, 1990

HYCULT DIAMOND CORONARY BYPASS KNIFE

Cardiovascular · 52d

Cleared Sep 26, 1989

ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP

Cardiovascular · 98d