510(k) K113335 ยท DQO Catheter, Intravascular, Diagnostic
HEARTRAIL III GUIDING CATHETER
| Applicant | Terumo Corporation, Shibuya-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Jul 16, 2012 |
| Received | Nov 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113335
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.