FDA 510(k)

15L 循环器引流袋

K号: K214016 · 2022-03-18

决定日期2022-03-18

产品代码KDJ

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决定实质等同

器械摘要

15L Cycler Drainage Bag is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K214016. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 15L Cycler Drainage Bag?

15L Cycler Drainage Bag is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K214016.

When did 15L Cycler Drainage Bag receive FDA 510(k) clearance?

15L Cycler Drainage Bag received FDA 510(k) clearance on 2022-03-18, under 510(k) number K214016.

Who is the listed applicant for 15L Cycler Drainage Bag?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 15L Cycler Drainage Bag?

The FDA product code for 15L Cycler Drainage Bag is KDJ.

列明Baxter Healthcare Corporation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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相关器械（代码：KDJ）

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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