Cleared Traditional

Terumo Advanced Perfusion System 1

K221895 · Terumo Cardiovascular Systems Corporation · Cardiovascular
Apr 2023
Decision
292d
Days
Class 2
Risk

About This 510(k) Submission

K221895 is an FDA 510(k) clearance for the Terumo Advanced Perfusion System 1, a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II — Special Controls, product code DTQ), submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on April 18, 2023, 292 days after receiving the submission on June 30, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4220.

Submission Details

510(k) Number K221895 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2022
Decision Date April 18, 2023
Days to Decision 292 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTQ — Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4220

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