FDA 510(k)

Zenysis 短期透析导管

K号: K153190 · 2016-01-05

决定日期2016-01-05

产品代码MPB

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决定实质等同

器械摘要

Zenysis Short-Term Dialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K153190. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zenysis Short-Term Dialysis Catheter?

Zenysis Short-Term Dialysis Catheter is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153190.

When did Zenysis Short-Term Dialysis Catheter receive FDA 510(k) clearance?

Zenysis Short-Term Dialysis Catheter received FDA 510(k) clearance on 2016-01-05, under 510(k) number K153190.

Who is the listed applicant for Zenysis Short-Term Dialysis Catheter?

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

What is the FDA product code for Zenysis Short-Term Dialysis Catheter?

The FDA product code for Zenysis Short-Term Dialysis Catheter is MPB.

列明C.R. Bard, Inc.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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