FDA 510(k)

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

K号: K250610 · 2025-06-27

决定日期2025-06-27

产品代码DWF

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明Sorin Group Italia S.R.L.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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