FDA 510(k)

Argos Infinity (Rev. 1.0)

K号: K253092 · 2026-02-13

决定日期2026-02-13

产品代码DXG

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

Argos Infinity (Rev. 1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Retia Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K253092. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Argos Infinity (Rev. 1.0)?

Argos Infinity (Rev. 1.0) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Retia Medical Systems, Inc.. The 510(k) number is K253092.

When did Argos Infinity (Rev. 1.0) receive FDA 510(k) clearance?

Argos Infinity (Rev. 1.0) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K253092.

Who is the listed applicant for Argos Infinity (Rev. 1.0)?

The FDA 510(k) record lists Retia Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Argos Infinity (Rev. 1.0)?

The FDA product code for Argos Infinity (Rev. 1.0) is DXG.

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Argos Infinity (Rev. 1.0)

器械摘要

常见问题

相关临床试验

相关器械（代码：DXG）

官方来源