510(k) K183045 ยท MJN Catheter, Intravascular Occluding, Temporary
Eclipse 2L
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 30, 2019 |
| Received | Nov 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183045
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.