510(k) K242503

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) by Eurosets S.R.L — Product Code DTZ

K242503 is an FDA 510(k) premarket notification submitted by Eurosets S.R.L for the device "Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)". The FDA issued a decision of Substantially Equivalent on November 24, 2025. 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 5 other 510(k) clearances on record.