510(k) K964017 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
AFFINITY BLOOD PUMP SYSTEM
| Applicant | Avecor Cardiovascular, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 5, 1997 |
| Received | Oct 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964017
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.