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St. Jude Medical, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K172393 Advisor HD Grid Mapping Catheter, Sensor EnabledMTD2018-04-23 View
510(k) K163407 Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC2017-09-29 View
510(k) K161171 PressureWire X GuidewireDXO2016-08-15 View
510(k) K161102 Nanostim Introducer KitDYB2016-05-19 View
510(k) K160716 The Nanostim Introducer KitDYB2016-04-14 View
510(k) K073700 6F PROXIS SYSTEMDQY2008-10-02 View
510(k) K042734 SJM RIGID SADDLE RING MODEL RSAR-(SIZE)KRH2004-12-17 View
510(k) K022363 SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)KRH2002-09-19 View
510(k) K014161 SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)KRH2002-01-15 View
510(k) K014037 SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)KRH2002-01-04 View
510(k) K001367 FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXXDYB2000-05-31 View
510(k) K001346 ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XXDYB2000-05-24 View
510(k) K000119 SJM TAILOR ANNULOPLASTY RING, MODEL TARNKRH2000-02-17 View
510(k) K961246 SJM SEGUIN ANNULOPLASTY RING MODEL SAR-MKRH1997-02-14 View
510(k) K935184 REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATINGDSP1995-02-10 View
510(k) K933014 LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PIKFM1994-09-28 View
510(k) K921550 LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CPKFM1992-05-21 View
510(k) K902159 BIFLEX(TM) ANNULOPLASTY RINGKRH1991-01-18 View
510(k) K900379 HYCULT DIAMOND CORONARY BYPASS KNIFEDWS1990-03-19 View
510(k) K894255 ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMPKFM1989-09-26 View
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