FDA 510(k)

Penumbra LP 导线系统

K号: K230284 · 2023-10-25

决定日期2023-10-25

产品代码HCG

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决定实质等同

器械摘要

Penumbra LP Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K230284. 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 Penumbra LP Coil System?

Penumbra LP Coil System is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Penumbra, Inc.. The 510(k) number is K230284.

When did Penumbra LP Coil System receive FDA 510(k) clearance?

Penumbra LP Coil System received FDA 510(k) clearance on 2023-10-25, under 510(k) number K230284.

Who is the listed applicant for Penumbra LP Coil System?

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

What is the FDA product code for Penumbra LP Coil System?

The FDA product code for Penumbra LP Coil System is HCG.

列明Penumbra, 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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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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