510(k) K131041 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
ADVANCED PERFUSION SYSTEM 1
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 20, 2014 |
| Received | Apr 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131041
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.