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FDA 510(k)

Affinity NT Oxygenator with Cortiva BioActive Surface

K号: K162016 · 2016-09-21

申请人Medtronic, Inc.
决定日期2016-09-21
产品代码DTZ
咨询委员会CV
决定Substantially Equivalent

器械摘要

Affinity NT Oxygenator with Cortiva BioActive Surface is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K162016. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Affinity NT Oxygenator with Cortiva BioActive Surface?

Affinity NT Oxygenator with Cortiva BioActive Surface is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Medtronic, Inc.. The 510(k) number is K162016.

When did Affinity NT Oxygenator with Cortiva BioActive Surface receive FDA 510(k) clearance?

Affinity NT Oxygenator with Cortiva BioActive Surface received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162016.

Who is the listed applicant for Affinity NT Oxygenator with Cortiva BioActive Surface?

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

What is the FDA product code for Affinity NT Oxygenator with Cortiva BioActive Surface?

The FDA product code for Affinity NT Oxygenator with Cortiva BioActive Surface is DTZ.

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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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