Essenz HLM, Essenz ILBM— 510(k) K232291
Substantially EquivalentLivanova Deutschland, GmbH
FDA 510(k) clearance K232291 for Essenz HLM, Essenz ILBM, Substantially Equivalent on 2023-08-24. Applicant: Livanova Deutschland, GmbH.
Clearance details
- Applicant
- Livanova Deutschland, GmbH
- Product code
- Code DTQ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Munich, DE
Adverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.