FDA 510(k)

QuikClot Control+ 止血敷料

K号: K220971 · 2022-12-14

决定日期2022-12-14

产品代码POD

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决定实质等同

器械摘要

QuikClot Control+ Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Z-Medica, LLC. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K220971. The device is classified under product code POD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QuikClot Control+ Hemostatic Dressing?

QuikClot Control+ Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Z-Medica, LLC. The 510(k) number is K220971.

When did QuikClot Control+ Hemostatic Dressing receive FDA 510(k) clearance?

QuikClot Control+ Hemostatic Dressing received FDA 510(k) clearance on 2022-12-14, under 510(k) number K220971.

Who is the listed applicant for QuikClot Control+ Hemostatic Dressing?

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

What is the FDA product code for QuikClot Control+ Hemostatic Dressing?

The FDA product code for QuikClot Control+ Hemostatic Dressing is POD.

列明Z-Medica, 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。

K200167QuikClot Control+K181641QuikClot Radial

官方来源

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