K250821
- 510(k) number
- K250821
- Device name
- 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)
- Applicant
- Eurosets S.R.L IT
- Product code
- DTZ — Oxygenator, Cardiopulmonary Bypass
- Decision date
- 2025-12-12
- Date received
- 2025-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250821.pdf
Official FDA record: K250821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.