FDA 510(k)

DiLumen C2和工具支架

K号: K211819 · 2021-10-22

决定日期2021-10-22

产品代码FDF

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决定实质等同

器械摘要

DiLumen C2 and Tool Mount is the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K211819. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DiLumen C2 and Tool Mount?

DiLumen C2 and Tool Mount is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Lumendi, LLC. The 510(k) number is K211819.

When did DiLumen C2 and Tool Mount receive FDA 510(k) clearance?

DiLumen C2 and Tool Mount received FDA 510(k) clearance on 2021-10-22, under 510(k) number K211819.

Who is the listed applicant for DiLumen C2 and Tool Mount?

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 C2 and Tool Mount?

The FDA product code for DiLumen C2 and Tool Mount is FDF.

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 K210851DiLumen腔内介入平台（DiLumen）K183112DiLumen腔内介入刀（“DiLumen IK”®）K182540DiLumen腔内介入平台 K173405DiLumen腔内介入剪刀（DiLumen Is）K173317DiLumen C2; DiLumen工具支架

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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。