510(k) K121301 ยท QEZ Aspiration Thrombectomy Catheter
XPRESSWAY RX CATHETER (6F LD-VERISON)
| Applicant | Kaneka Pharma America, LLC, New York NY, US |
| Decision | Substantially Equivalent, Jul 30, 2012 |
| Received | May 1, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121301
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.