FDA 510(k)

Century Perfusion System

K-Number: K202125 · 2021-03-07

Decision Date2021-03-07

Product CodeDTQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Century Perfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Century Hlm, LLC. It received FDA 510(k) clearance on 2021-03-07 under 510(k) number K202125. 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 Century Perfusion System?

Century Perfusion System is a medical device that received FDA 510(k) clearance on 2021-03-07. The listed applicant is Century Hlm, LLC. The 510(k) number is K202125.

When did Century Perfusion System receive FDA 510(k) clearance?

Century Perfusion System received FDA 510(k) clearance on 2021-03-07, under 510(k) number K202125.

Who is the listed applicant for Century Perfusion System?

The FDA 510(k) record lists Century Hlm, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Century Perfusion System?

The FDA product code for Century Perfusion System is DTQ.

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, GmbH K221895Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation K221373Essenz HLMLivanova Deutschland, GmbH K210130Stockert S5 SystemLivanova Deutschland, GmbH K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)Spectrum Medical , Ltd.K173834Quantum Pump ConsoleSpectrum Medical , Ltd.

Official Source

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