510(k) K200648 ยท QEY Mechanical Thrombolysis Catheter
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
| Applicant | Ekos Corporation, Bothell WA, US |
| Decision | Substantially Equivalent, Aug 17, 2020 |
| Received | Mar 12, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2022 | Boston Scientific Corporation EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System. Open, Classified |
QEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.