FDA 510(k)

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

K-Nummer: K250610 · 2025-06-27

Entscheidungsdatum2025-06-27

ProduktcodeDWF

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K250610. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)?

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K250610.

When did Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) receive FDA 510(k) clearance?

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) received FDA 510(k) clearance on 2025-06-27, under 510(k) number K250610.

Who is the listed applicant for Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)?

The FDA product code for Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) is DWF.

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