510(k) K032128 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Aug 1, 2003 |
| Received | Jul 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032128
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.