510(k) K053217 ยท DQY Catheter, Percutaneous
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148
| Applicant | St Jude Medical, Sylmar CA, US |
| Decision | Substantially Equivalent, Mar 8, 2006 |
| Received | Nov 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2006 | St Jude Medical CRMD CPS Slitter, Model 410191 Terminated |
DQY | None listed |
| Jun 24, 2006 | St Jude Medical CRMD CPS Valve Bypass Tool (VBT), Model 410192 Terminated |
DQY | None listed |
| Jun 24, 2006 | St Jude Medical CRMD CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126 Terminated |
DQY | None listed |
| Jun 24, 2006 | St Jude Medical CRMD CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148 Terminated |
DQY | None listed |
| Jun 24, 2006 | St Jude Medical CRMD CPS Implant Kit, Model 410190 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.