Class Class II
Essenz HLM (K221373)
Description
Essenz HLM by Livanova Deutschland, GmbH, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221373
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodeDTQ
Regulation Number870.4220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221373
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Essenz HLM (K221373) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210130 | Stockert S5 System | Livanova Deutschland, GmbH | 2021 |
| K112225 | SORIN CENTRIFUGAL PUMP 5 (CP5) | Sorin Group Deutschland GmbH | 2011 |
| K082344 | STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) | Sorin Group Deutschland GmbH | 2008 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBM | Livanova Deutschland, GmbH | 2023 |
Trace the full predicate network for K221373
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.