510(k) K092575 ยท DYB Introducer, Catheter
ENGAGE/ENGAGE TR
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Oct 8, 2009 |
| Received | Aug 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | 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, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094. Terminated |
DYB | None listed |
| 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 | 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, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543. Terminated |
DYB | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.