FDA 510(k)

DiLumen腔内介入刀（“DiLumen IK”®）

K号: K183112 · 2019-08-02

决定日期2019-08-02

产品代码GEI

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决定实质等同

器械摘要

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K183112. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Lumendi, LLC. The 510(k) number is K183112.

When did DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) receive FDA 510(k) clearance?

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) received FDA 510(k) clearance on 2019-08-02, under 510(k) number K183112.

Who is the listed applicant for DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

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

What is the FDA product code for DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)?

The FDA product code for DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) is GEI.

列明Lumendi, 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。

K221452DiLumen C1, EZ1和工具支架 K211819DiLumen C2和工具支架 K210851DiLumen腔内介入平台（DiLumen）K182540DiLumen腔内介入平台 K173405DiLumen腔内介入剪刀（DiLumen Is）K173317DiLumen C2; DiLumen工具支架

查看所有 8 个设备 →

相关器械（代码：GEI）

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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