510(k) K053277 ยท DQY Catheter, Percutaneous
CPS DIRECT SL OUTER CATHETER
| Applicant | St Jude Medical, Sylmar CA, US |
| Decision | Substantially Equivalent, Feb 24, 2006 |
| Received | Nov 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2007 | St Jude Medical CRMD St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126. Terminated |
MCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.