FDA 510(k)

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16

K号: K161584 · 2016-10-06

决定日期2016-10-06

产品代码DQX

咨询委员会CV

决定Substantially Equivalent

器械摘要

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 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 2016-10-06 under 510(k) number K161584. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161584.

When did ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 receive FDA 510(k) clearance?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161584.

Who is the listed applicant for ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16?

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® Peripheral Vascular Guide Wire ASAHI Meister®16?

The FDA product code for ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 is DQX.

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。

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相关器械（代码：DQX）

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。

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官方来源

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