Company
St. Jude Medical Cardiovascular Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2011 | St. Jude Medical Cardiovascular Division MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium.
Indicted for th Terminated |
DWS | None listed |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094. Terminated |
DYB | K091137 K092575 +1 |
| Aug 12, 2010 | St. Jude Medical Cardiovascular Division St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093. Terminated |
DYB | K091137 K092575 +1 |
| Sep 20, 2008 | St. Jude Medical Cardiovascular Division The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345- Terminated |
LPB | None listed |