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. Device class: 2.
Clearance details
- Applicant
- Livanova Deutschland, GmbH
- Product code
- Code DTQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Munich, DE
Recent devices under product code DTQ
view allMore clearances from Livanova Deutschland, GmbH
view allAdverse 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 →
Recalls naming K232291
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232291.
Data sourced from openFDA. This site is unofficial and independent of the FDA.