510(k) K163531 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Advanced Perfusion System 1
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jun 7, 2017 |
| Received | Dec 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163531
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.