FDA 510(k)

Proxis 肾盂输尿管通道鞘

K号: K160861 · 2016-03-31

决定日期2016-03-31

产品代码FED

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决定实质等同

器械摘要

Proxis Ureteral Access Sheath 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 2016-03-31 under 510(k) number K160861. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Proxis Ureteral Access Sheath?

Proxis Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K160861.

When did Proxis Ureteral Access Sheath receive FDA 510(k) clearance?

Proxis Ureteral Access Sheath received FDA 510(k) clearance on 2016-03-31, under 510(k) number K160861.

Who is the listed applicant for Proxis Ureteral Access Sheath?

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 Proxis Ureteral Access Sheath?

The FDA product code for Proxis Ureteral Access Sheath is FED.

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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