K232291 is an FDA 510(k) clearance for the Essenz HLM, Essenz ILBM. This device is classified as a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II - Special Controls, product code DTQ).
Submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on August 24, 2023, 23 days after receiving the submission on August 1, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4220.
| 510(k) Number | K232291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2023 |
| Decision Date | August 24, 2023 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTQ - Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4220 |