FDA 510(k)

CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention

K号: K213081 · 2021-10-26

决定日期2021-10-26

产品代码IZF

咨询委员会RA

决定实质等同

器械摘要

CLISIS SYSTEMS, Discovery RF180 is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Merate S.P.A. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K213081. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CLISIS SYSTEMS, Discovery RF180?

CLISIS SYSTEMS, Discovery RF180 is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is General Medical Merate S.P.A. The 510(k) number is K213081.

When did CLISIS SYSTEMS, Discovery RF180 receive FDA 510(k) clearance?

CLISIS SYSTEMS, Discovery RF180 received FDA 510(k) clearance on 2021-10-26, under 510(k) number K213081.

Who is the listed applicant for CLISIS SYSTEMS, Discovery RF180?

The FDA 510(k) record lists General Medical Merate S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLISIS SYSTEMS, Discovery RF180?

The FDA product code for CLISIS SYSTEMS, Discovery RF180 is IZF.

列明General Medical Merate S.P.A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。

K173395MECALL CLISIS SYSTEMS, Discovery RF180

官方来源

在 FDA 数据库中查看 →

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。