FDA 510(k)

Century Perfusion System

Número K: K202125 · 2021-03-07

Data da decisão2021-03-07

Código do produtoDTQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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