K242503

Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

510(k) number: K242503
Device name: Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
Applicant: Eurosets S.R.L IT
Product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Decision date: 2025-11-24
Date received: 2024-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

Also available from FDA: K242503.pdf

Official FDA record: K242503

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.