510(k) K191402 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
Heater-Cooler System 3T
| Applicant | Livanova Deutschland, GmbH, Munich, DE |
| Decision | Substantially Equivalent, Feb 25, 2020 |
| Received | May 24, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2023 | LivaNova Deutschland GmbH 3T Heater Cooler System, REF: 16-02-85 Open, Classified |
DWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.