510(k) K223305 ยท POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Trevo NXT ProVue Retriever
| Applicant | Stryker Neurovascular, Fremont CA, US |
| Decision | Substantially Equivalent, Mar 29, 2023 |
| Received | Oct 27, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223305
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2024 | Stryker Neurovascular Trevo NXT ProVue 3 x 32, US, Catalog: 90312
Kits:
TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412
TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413
TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 Open, Classified |
POL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.