510(k) K091029 ยท MCW Catheter, Peripheral, Atherectomy
CLEANER ROTATIONAL THROMBECTOMY SYSTEM (9 MM X 65 CM) AND (9 MM X 120 CM)
| Applicant | Rex Medical, Great Neck NY, US |
| Decision | Substantially Equivalent, Feb 18, 2010 |
| Received | Apr 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091029
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.