510(k) K211080 ยท QEY Mechanical Thrombolysis Catheter
EkoSonic Endovascular Device
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 19, 2021 |
| Received | Apr 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211080
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.