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FDA 510(k)

Stockert S5 System

K-Number: K210130 · 2021-04-05

ApplicantLivanova Deutschland, GmbH
Decision Date2021-04-05
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stockert S5 System 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 2021-04-05 under 510(k) number K210130. 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 Stockert S5 System?

Stockert S5 System is a medical device that received FDA 510(k) clearance on 2021-04-05. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K210130.

When did Stockert S5 System receive FDA 510(k) clearance?

Stockert S5 System received FDA 510(k) clearance on 2021-04-05, under 510(k) number K210130.

Who is the listed applicant for Stockert S5 System?

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 Stockert S5 System?

The FDA product code for Stockert S5 System is DTQ.

Other records listing Livanova Deutschland, GmbH as applicant

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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 CorporationK221373Essenz HLMLivanova 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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