K221373 is an FDA 510(k) clearance for the Essenz HLM. 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 March 9, 2023, 301 days after receiving the submission on May 12, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4220.
| 510(k) Number | K221373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2022 |
| Decision Date | March 09, 2023 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| 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 |