Company ยท US
St. Jude Medical, Cardiac Rhythm Management Divisi
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2012. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2012 | K122090 | SJM CONFIRM IMPLANTABLE CARDIAC MONITOR St. Jude Medical, Cardiac Rhythm Management Divisi | MXC |
| May 11, 2012 | K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| May 8, 2012 | K120298 | CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE St. Jude Medical, Cardiac Rhythm Management Divisi | DQX |
| Sep 29, 2011 | K111943 | AGILLS PF DELIVERY SYSTEM St. Jude Medical, Cardiac Rhythm Management Divisi | DYB |
| Jan 19, 2011 | K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Apr 2, 2010 | K093858 | PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A St. Jude Medical, Cardiac Rhythm Management Divisi | DSA |
| Aug 7, 2009 | K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Jul 1, 2009 | K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Apr 30, 2008 | K080924 | MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 St. Jude Medical, Cardiac Rhythm Management Divisi | DRB |
| Mar 13, 2008 | K072864 | ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM St. Jude Medical, Cardiac Rhythm Management Divisi | DRB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||