Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)— 510(k) K250610

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K250610 for Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310), Substantially Equivalent on 2025-06-27. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2025-02-28
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.