510(k) K210130 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Stockert S5 System
| Applicant | Livanova Deutschland, GmbH, Munich, DE |
| Decision | Substantially Equivalent, Apr 5, 2021 |
| Received | Jan 19, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210130
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.