510(k) K070051 ยท DQY Catheter, Percutaneous
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 6, 2007 |
| Received | Jan 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070051
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.