510(k) K182918 ยท DQY Catheter, Percutaneous
Ballast 088 Long Sheath
| Applicant | Balt USA, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 21, 2019 |
| Received | Oct 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182918
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.