510(k) K232291 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Essenz HLM, Essenz ILBM
| Applicant | Livanova Deutschland, GmbH, Munich, DE |
| Decision | Substantially Equivalent, Aug 24, 2023 |
| Received | Aug 1, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2024 | LivaNova Deutschland GmbH Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software Open, Classified |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.