510(k) K261438

HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) by Eurosets S.R.L — Product Code DTZ

K261438 is an FDA 510(k) premarket notification submitted by Eurosets S.R.L for the device "HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)". The FDA issued a decision of Substantially Equivalent on September 14, 2026. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Eurosets S.R.L has at least 6 other 510(k) clearances on record.