K242503
- 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
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
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.