510(k) K072313 ยท DQY Catheter, Percutaneous
AMPLATZER TORQVUE DELIVERY SYSTEM
| Applicant | Aga Medical Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 2, 2007 |
| Received | Aug 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2010 | AGA Medical Corporation AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.