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

St. Jude Medical, Inc. was a global medical device company headquartered in Little Canada, Minnesota. The company operated more than 20 principal facilities worldwide and sold products in over 100 countries.

St. Jude Medical received 22 FDA 510(k) clearances from 23 total submissions between 1989 and 2018. The company specialized exclusively in Cardiovascular devices, establishing a focused portfolio in cardiac monitoring, catheter systems, and related interventional technologies.

Founded in 1976 and publicly listed in 1977, St. Jude Medical achieved Fortune 500 status annually since 2010. The company was acquired by Abbott Laboratories in January 2017 and now operates as part of Abbott's medical device portfolio.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.

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

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