K250610
- 510(k) number
- K250610
- Device name
- Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- Applicant
- Sorin Group Italia S.R.L. IT
- Product code
- DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmon
- Decision date
- 2025-06-27
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250610.pdf
Official FDA record: K250610
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.