510(k) K101839 ยท QEZ Aspiration Thrombectomy Catheter
KANEKA PHARMA AMERICA XPRESS-WAY RX
| Applicant | Kaneka Pharma America, LLC, Hudson NH, US |
| Decision | Substantially Equivalent, Oct 22, 2010 |
| Received | Jul 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101839
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.