FDA 510(k)

LimFlow ARC

K号: K251376 · 2025-05-31

决定日期2025-05-31

产品代码PDU

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

LimFlow ARC is the device name listed in this FDA 510(k) record. The listed applicant is LimFlow, Inc.. It received FDA 510(k) clearance on 2025-05-31 under 510(k) number K251376. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LimFlow ARC?

LimFlow ARC is a medical device that received FDA 510(k) clearance on 2025-05-31. The listed applicant is LimFlow, Inc.. The 510(k) number is K251376.

When did LimFlow ARC receive FDA 510(k) clearance?

LimFlow ARC received FDA 510(k) clearance on 2025-05-31, under 510(k) number K251376.

Who is the listed applicant for LimFlow ARC?

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

What is the FDA product code for LimFlow ARC?

The FDA product code for LimFlow ARC is PDU.

列明LimFlow, Inc.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。

K260188LimFlow Vector K242776LimFlow V-Ceiver K221902LimFlow Vector K221541LimFlow ARC K222083LimFlow V-Ceiver

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。