FDA 510(k)

ClearPetra 吸引-排空套管

K号: K203119 · 2020-12-09

决定日期2020-12-09

产品代码FED

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决定实质等同

器械摘要

ClearPetra Suction-Evacuation Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-09 under 510(k) number K203119. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ClearPetra Suction-Evacuation Sheath?

ClearPetra Suction-Evacuation Sheath is a medical device that received FDA 510(k) clearance on 2020-12-09. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K203119.

When did ClearPetra Suction-Evacuation Sheath receive FDA 510(k) clearance?

ClearPetra Suction-Evacuation Sheath received FDA 510(k) clearance on 2020-12-09, under 510(k) number K203119.

Who is the listed applicant for ClearPetra Suction-Evacuation Sheath?

The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPetra Suction-Evacuation Sheath?

The FDA product code for ClearPetra Suction-Evacuation Sheath is FED.

列明Well Lead Medical Co., Ltd.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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