510(k) K191119 ยท QEY Mechanical Thrombolysis Catheter
EkoSonic Endovascular Device
| Applicant | Btg International, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | Apr 26, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191119
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.