510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232291Substantially Equivalent

Essenz HLM, Essenz ILBM

LivaNova Deutschland GmbH, Munich, DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232291 is the FDA 510(k) clearance record for Essenz HLM, Essenz ILBM, a class II device, cleared for Livanova Deutschland, GmbH on under FDA product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass). FDA records list 27 510(k) clearances for Livanova Deutschland, GmbH, from to . As of , FDA records show one recall naming K232291.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation
21 CFR 870.4220
Device class
Class II
Review panel
Cardiovascular
Applicant
Livanova Deutschland, GmbH Lindberghstr. 25, Munich, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTQ

Trailing 12 months

FDA records hold no clearances under product code DTQ in the trailing twelve months.

FDA records show no clearances under product code DTQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260