510(k) K130520 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
| Applicant | Ashitaka Factory of Terumo Corp., Fujinomiya Shizuoka, JP |
| Decision | Substantially Equivalent, Mar 13, 2013 |
| Received | Feb 28, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130520
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.