FDA 510(k)

Ahmed 慢性青光眼阀门

K号: K162060 · 2016-10-24

决定日期2016-10-24

产品代码KYF

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决定实质等同

器械摘要

Ahmed Glaucoma Valve is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K162060. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ahmed Glaucoma Valve?

Ahmed Glaucoma Valve is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is New World Medical, Inc.. The 510(k) number is K162060.

When did Ahmed Glaucoma Valve receive FDA 510(k) clearance?

Ahmed Glaucoma Valve received FDA 510(k) clearance on 2016-10-24, under 510(k) number K162060.

Who is the listed applicant for Ahmed Glaucoma Valve?

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

What is the FDA product code for Ahmed Glaucoma Valve?

The FDA product code for Ahmed Glaucoma Valve is KYF.

列明New World Medical, 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。

K243503VIA360™ 手术系统 K220891Kahook双刀片滑行（KDB滑行）K231051Ahmed® 慢性青光眼阀门型号 FP8 K230975Ahmed® 慢性青光眼阀门型号 FP7 K211680Streamline外科系统 K182518AHMED ClearPath青光眼引流装置

查看所有 8 个设备 →

官方来源

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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。