FDA 510(k)

i-ED线圈系统

K号: K210638 · 2021-03-26

决定日期2021-03-26

产品代码HCG

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决定实质等同

器械摘要

i-ED COIL System is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Medical America, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210638. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i-ED COIL System?

i-ED COIL System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Kaneka Medical America, LLC. The 510(k) number is K210638.

When did i-ED COIL System receive FDA 510(k) clearance?

i-ED COIL System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210638.

Who is the listed applicant for i-ED COIL System?

The FDA 510(k) record lists Kaneka Medical America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-ED COIL System?

The FDA product code for i-ED COIL System is HCG.

列明Kaneka Medical America, LLC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。

K213166Thrombuster II 吸引导管

相关器械（代码：HCG）

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。

官方来源

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