Cleared Special

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)

K250610 · Sorin Group Italia S.R.L. · Cardiovascular

Jun 2025

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K250610 is an FDA 510(k) clearance for the Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on June 27, 2025, 119 days after receiving the submission on February 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K250610 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2025
Decision Date	June 27, 2025
Days to Decision	119 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210