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FDA 510(k)

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

K-Number: K250610 · 2025-06-27

ApplicantSorin Group Italia S.R.L.
Decision Date2025-06-27
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K250610.

When was Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) approved by the FDA?

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

What company makes Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)?

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) is manufactured by Sorin Group Italia S.R.L..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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