510(k) K010443 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Dec 11, 2001 |
| Received | Feb 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010443
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.