510(k) K121611 ยท DQY Catheter, Percutaneous
AMPLATZER TORQVUE FX
| Applicant | Aga Medical Corporation, Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 23, 2012 |
| Received | Jun 1, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2013 | St Jude Medical Inc St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITV Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.