Cleared Traditional

Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)

K250821 · Eurosets Srl · Cardiovascular
Dec 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K250821 is an FDA 510(k) clearance for the Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073), a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Eurosets Srl (Medolla, IT). The FDA issued a Cleared decision on December 12, 2025, 269 days after receiving the submission on March 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K250821 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2025
Decision Date December 12, 2025
Days to Decision 269 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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