510(k) K163000 ยท DQY Catheter, Percutaneous
AMPLATZER TorqVue 45x45 Delivery Sheath
| Applicant | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO, Plymouth MN, US |
| Decision | Substantially Equivalent, Dec 23, 2016 |
| Received | Oct 28, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163000
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.