FDA 510(k)

FFRct

K号: K152733 · 2016-01-13

决定日期2016-01-13

产品代码PJA

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

FFRct is the device name listed in this FDA 510(k) record. The listed applicant is HeartFlow, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152733. The device is classified under product code PJA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FFRct?

FFRct is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is HeartFlow, Inc.. The 510(k) number is K152733.

When did FFRct receive FDA 510(k) clearance?

FFRct received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152733.

Who is the listed applicant for FFRct?

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

What is the FDA product code for FFRct?

The FDA product code for FFRct is PJA.

列明HeartFlow, 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。

K250902HeartFlow 分析 K213857HeartFlow 分析 K203329HeartFlow 分析 K190925HeartFlow FFRct 分析 K182035FFRct K161772FFRct

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官方来源

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