FDA 510(k)

Makoto血管内成像系统，Dualpro IVUS + NIRS成像导管

K号: K183599 · 2019-04-12

决定日期2019-04-12

产品代码OGZ

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

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Infraredx, Inc.. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K183599. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Infraredx, Inc.. The 510(k) number is K183599.

When did Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter receive FDA 510(k) clearance?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter received FDA 510(k) clearance on 2019-04-12, under 510(k) number K183599.

Who is the listed applicant for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

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

What is the FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

The FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is OGZ.

列明Infraredx, 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。

K241576Makoto血管内成像系统®（VC-MC10 / TVC-MC10i）；Dualpro® IVUS+NIRS成像导管（TVC-C195-42）；外周014成像导管（TVC-E195-42 ）K213303Makoto血管内成像系统，TVC-MC10/TVC-MC10i，Dualpro IVUS + NIRS成像导管，TVC-C195-42，外周014成像导管，TVC-E195-42 K163345TVC成像系统，TVC导管

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