510(k) K002238 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Aug 22, 2000 |
| Received | Jul 24, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002238
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.