510(k) K181354 ยท NRY Catheter, Thrombus Retriever
074 Zenith Flex System
| Applicant | Inneuroco, Inc., Sunrise FL, US |
| Decision | Substantially Equivalent, Oct 25, 2018 |
| Received | May 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2019 | Stryker Neurovascular Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, Terminated |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.