Atlas FDA

Essenz HLM, Essenz ILBM

FDA 510(k) clearance K232291 · decided 2023-08-24

Clearance details

K-number
K232291
Device name
Essenz HLM, Essenz ILBM
Applicant
Livanova Deutschland, GmbH
Decision
Substantially Equivalent
Date received
2023-08-01
Decision date
2023-08-24
Days to decision
23 days
Clearance type
Special
Product code
DTQ
Device class
2
Regulation number
870.4220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Munich, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software recall (Z-0571-2025)LivaNova Deutschland GmbH2024-11-27