FDA 510(k)

ASAHI CHIKAI 神经血管导丝（圆曲线）

K号: K160659 · 2016-04-07

决定日期2016-04-07

产品代码MOF

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

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K160659. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)?

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K160659.

When did ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) receive FDA 510(k) clearance?

ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) received FDA 510(k) clearance on 2016-04-07, under 510(k) number K160659.

Who is the listed applicant for ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)?

The FDA product code for ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) is MOF.

列明Asahi Intecc Co., Ltd.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。

K254178SAYA 86 桡动脉通路导丝导管 K252011CHIKAI Nexus petit K251560FUBUKI XF-R 神经血管长鞘 K251240Branchor X 气球引导导管 K243383CHIKAI Nexus 014 K243733SION blue PLUS

查看所有 45 个设备 →

官方来源

在 FDA 数据库中查看 →

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。