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FDA 510(k)

Essenz HLM

K-Number: K221373 · 2023-03-09

ApplicantLivanova Deutschland, GmbH
Decision Date2023-03-09
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Essenz HLM is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K221373. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Essenz HLM?

Essenz HLM is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K221373.

When did Essenz HLM receive FDA 510(k) clearance?

Essenz HLM received FDA 510(k) clearance on 2023-03-09, under 510(k) number K221373.

Who is the listed applicant for Essenz HLM?

The FDA 510(k) record lists Livanova Deutschland, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Essenz HLM?

The FDA product code for Essenz HLM is DTQ.

Other records listing Livanova Deutschland, GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232291Essenz HLM, Essenz ILBMK220635Heater-Cooler System 3TK212003ESSENZ Patient MonitorK210130Stockert S5 SystemK202154B-CaptaK191402Heater-Cooler System 3T

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Related Devices (Code: DTQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationK210130Stockert S5 SystemLivanova Deutschland, GmbHK202125Century Perfusion SystemCentury Hlm, LLCK190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.K173834Quantum Pump ConsoleSpectrum Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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