510(k) K080757 ยท DQY Catheter, Percutaneous
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
| Applicant | Aga Medical Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 18, 2008 |
| Received | Mar 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080757
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.