FDA 510(k)

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip

K号: K161912 · 2016-10-14

决定日期2016-10-14

产品代码MOF

咨询委员会CV

决定Substantially Equivalent

器械摘要

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip 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 2016-10-14 under 510(k) number K161912. 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 Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K161912.

When did ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip receive FDA 510(k) clearance?

ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161912.

Who is the listed applicant for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

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 Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip?

The FDA product code for ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip 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。

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官方来源

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