FDA 510(k) Applications Submitted by St. Jude Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K131592 |
06/03/2013 |
ENLIGHTN RENAL GUIDE CATHETER |
ST. JUDE MEDICAL, INC. |
| K140793 |
03/31/2014 |
NANOSTIM INTRODUCER KIT |
ST. JUDE MEDICAL, INC. |
| K163407 |
12/05/2016 |
Confirm Rx Insertable Cardiac Monitor (ICM) System |
St. Jude Medical, Inc. |
| K172393 |
08/08/2017 |
Advisor HD Grid Mapping Catheter, Sensor Enabled |
St. Jude Medical, Inc. |
| K961246 |
04/01/1996 |
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M |
ST. JUDE MEDICAL, INC. |
| K073700 |
12/31/2007 |
6F PROXIS SYSTEM |
ST. JUDE MEDICAL, INC. |
| K133481 |
11/13/2013 |
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) |
ST. JUDE MEDICAL, INC. |
| K001346 |
04/28/2000 |
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX |
ST. JUDE MEDICAL, INC. |
| K001367 |
05/01/2000 |
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX |
ST. JUDE MEDICAL, INC. |
| K000119 |
01/18/2000 |
SJM TAILOR ANNULOPLASTY RING, MODEL TARN |
ST. JUDE MEDICAL, INC. |
| K042734 |
10/01/2004 |
SJM RIGID SADDLE RING MODEL RSAR-(SIZE) |
ST. JUDE MEDICAL, INC. |
| K014037 |
12/07/2001 |
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) |
ST. JUDE MEDICAL, INC. |
| K014161 |
12/19/2001 |
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) |
ST. JUDE MEDICAL, INC. |
| K022363 |
07/22/2002 |
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND) |
ST. JUDE MEDICAL, INC. |
|
|
