510(k) K130359 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Mar 13, 2013 |
| Received | Feb 13, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130359
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.