510(k) K011804 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | Jun 11, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011804
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.