510(k) K162771 ยท QEY Mechanical Thrombolysis Catheter
EkoSonic Endovascular System with Control Unit 4.0
| Applicant | Btg International, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Feb 24, 2017 |
| Received | Oct 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162771
| 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.