Cleared Special

Essenz HLM, Essenz ILBM

K232291 · Livanova Deutschland, GmbH · Cardiovascular
Aug 2023
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K232291 is an FDA 510(k) clearance for the Essenz HLM, Essenz ILBM, 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 August 24, 2023, 23 days after receiving the submission on August 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4220.

Submission Details

510(k) Number K232291 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2023
Decision Date August 24, 2023
Days to Decision 23 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTQ — Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4220

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