510(k) K213422 ยท QEY Mechanical Thrombolysis Catheter
EkoSonic Endovascular Device, EKOS+ Endovascular Device
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Dec 14, 2021 |
| Received | Oct 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213422
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2022 | Boston Scientific Corporation EkoSonic Kit 135cm, 12cm TZ
The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. Open, Classified |
QEY | None listed |
| May 25, 2022 | Boston Scientific Corporation EkoSonic Kit 106cm, 12cm TZ
The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. Open, Classified |
QEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.