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FDA 510(k)

Century Perfusion System

K-Number: K202125 · 2021-03-07

ApplicantCentury Hlm, LLC
Decision Date2021-03-07
Product CodeDTQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Century Perfusion System is a medical device manufactured by Century Hlm, LLC. It received FDA 510(k) clearance on 2021-03-07 under approval 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. It is manufactured by Century Hlm, LLC. The 510(k) number is K202125.

When was Century Perfusion System approved by the FDA?

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

What company makes Century Perfusion System?

Century Perfusion System is manufactured by Century Hlm, LLC.

What is the FDA product code for Century Perfusion System?

The FDA product code for Century Perfusion System is DTQ.

Related Clinical Trials

NCT05574361 Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) ACTIVE_NOT_RECRUITING NCT07556588 XVIVO Heart Transplant Study in Clinical Practice RECRUITING NCT05101460 An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant ACTIVE_NOT_RECRUITING NCT06485596 HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. ACTIVE_NOT_RECRUITING NCT05881278 XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS) ACTIVE_NOT_RECRUITING

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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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