510(k) K192122 ยท DQO Catheter, Intravascular, Diagnostic
Trevo Trak 21 Microcatheter
| Applicant | Stryker, Fremont CA, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Aug 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2022 | Stryker Neurovascular Trevo Trak 21 Microcatheter, REF: 90338.
TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412;
TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;
TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414;
TREVO NXT 6X37+TR Open, Classified |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.