FDA 510(k)

XenMatrix AB 外科移植物

K号: K162193 · 2016-12-23

决定日期2016-12-23

产品代码PIJ

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决定实质等同

器械摘要

XenMatrix AB Surgical Graft is the device name listed in this FDA 510(k) record. The listed applicant is C. R. Bard. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K162193. The device is classified under product code PIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XenMatrix AB Surgical Graft?

XenMatrix AB Surgical Graft is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is C. R. Bard. The 510(k) number is K162193.

When did XenMatrix AB Surgical Graft receive FDA 510(k) clearance?

XenMatrix AB Surgical Graft received FDA 510(k) clearance on 2016-12-23, under 510(k) number K162193.

Who is the listed applicant for XenMatrix AB Surgical Graft?

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

What is the FDA product code for XenMatrix AB Surgical Graft?

The FDA product code for XenMatrix AB Surgical Graft is PIJ.

列明C. R. Bard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。

K190527GlidePath 长期血液透析导管，HemoStar 长期血液透析导管，HemoStar XK 长期血液透析导管 K182281Site~Rite 8 超声系统带 Cue 尖端跟踪系统和 Pinpoint GT 尖端技术 K172571ULTRASCORE聚焦力量PTA球囊 K170294VENTRALIGHT ST 网格配合 ECHO 2 定位系统 11cm（4.5英寸）圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 10cm x 15cm（4英寸x 6英寸）椭圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 15cm（6英寸）圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 15cm x 20cm（6英寸x8英寸）椭圆形，VENTRALIGHT ST 网格配合 ECHO 2 定位系统 15cm x 25cm（6英寸x10英寸）椭圆形

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

列明C. R. Bard为申报人的其他记录

官方来源