FDA 510(k)

AHMED ClearPath青光眼引流装置

K号: K182518 · 2019-01-18

决定日期2019-01-18

产品代码KYF

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决定实质等同

器械摘要

AHMED ClearPath Glaucoma Drainage Device 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 2019-01-18 under 510(k) number K182518. 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 ClearPath Glaucoma Drainage Device?

AHMED ClearPath Glaucoma Drainage Device is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is New World Medical, Inc.. The 510(k) number is K182518.

When did AHMED ClearPath Glaucoma Drainage Device receive FDA 510(k) clearance?

AHMED ClearPath Glaucoma Drainage Device received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182518.

Who is the listed applicant for AHMED ClearPath Glaucoma Drainage Device?

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 ClearPath Glaucoma Drainage Device?

The FDA product code for AHMED ClearPath Glaucoma Drainage Device 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。

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官方来源

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