Cleared Traditional

Century Perfusion System

K202125 · Century Hlm, LLC · Cardiovascular

Mar 2021

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K202125 is an FDA 510(k) clearance for the Century Perfusion System, a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II — Special Controls, product code DTQ), submitted by Century Hlm, LLC (Mesa, US). The FDA issued a Cleared decision on March 7, 2021, 219 days after receiving the submission on July 31, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4220.

Submission Details

510(k) Number	K202125 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2020
Decision Date	March 07, 2021
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF