Cleared Traditional

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System

K203111 · Medtronic · Cardiovascular
Sep 2021
Decision
336d
Days
Class 2
Risk

About This 510(k) Submission

K203111 is an FDA 510(k) clearance for the Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Medtronic (Minneapolis, US). The FDA issued a Cleared decision on September 16, 2021, 336 days after receiving the submission on October 15, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K203111 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2020
Decision Date September 16, 2021
Days to Decision 336 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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