FDA 510(k)

CATSmart，自动血液处理自体输血系统

K号: K210089 · 2021-02-11

决定日期2021-02-11

产品代码CAC

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决定实质等同

器械摘要

CATSmart, Automated Blood Processing Autotransfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Kabi AG. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K210089. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CATSmart, Automated Blood Processing Autotransfusion System?

CATSmart, Automated Blood Processing Autotransfusion System is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Fresenius Kabi AG. The 510(k) number is K210089.

When did CATSmart, Automated Blood Processing Autotransfusion System receive FDA 510(k) clearance?

CATSmart, Automated Blood Processing Autotransfusion System received FDA 510(k) clearance on 2021-02-11, under 510(k) number K210089.

Who is the listed applicant for CATSmart, Automated Blood Processing Autotransfusion System?

The FDA 510(k) record lists Fresenius Kabi AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATSmart, Automated Blood Processing Autotransfusion System?

The FDA product code for CATSmart, Automated Blood Processing Autotransfusion System is CAC.

列明Fresenius Kabi AG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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