510(k) K213166 ยท QEZ Aspiration Thrombectomy Catheter
Thrombuster II Aspiration Catheter
| Applicant | Kaneka Medical America, LLC, New York NY, US |
| Decision | Substantially Equivalent, Oct 26, 2021 |
| Received | Sep 28, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213166
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.