Cleared Special

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

K241352 · Medtronic, Inc. · Cardiovascular
Jun 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241352 is an FDA 510(k) clearance for the Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B), a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 12, 2024, 30 days after receiving the submission on May 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K241352 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2024
Decision Date June 12, 2024
Days to Decision 30 days
Submission Type Special
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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