FDA 510(k)

Arrow 硬膜外导管套装

K号: K161075 · 2016-10-04

决定日期2016-10-04

产品代码CAZ

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决定实质等同

器械摘要

Arrow Epidural Catheter Kit is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-10-04 under 510(k) number K161075. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arrow Epidural Catheter Kit?

Arrow Epidural Catheter Kit is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K161075.

When did Arrow Epidural Catheter Kit receive FDA 510(k) clearance?

Arrow Epidural Catheter Kit received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161075.

Who is the listed applicant for Arrow Epidural Catheter Kit?

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

What is the FDA product code for Arrow Epidural Catheter Kit?

The FDA product code for Arrow Epidural Catheter Kit is CAZ.

列明Teleflexmedical, 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。

K232469Rüsch 橡胶金 Foley 导尿管 K212077Teleflex Rusch SoftSimplastic Foley 导尿管 K192324Sheridan 螺旋柔性气管插管 K182847Hudson RCI Voldyne 体积训练器 K181979Rusch FloCath 快速 18 Fr. 弯曲型亲水间歇性导管 K183461Rusch 亲水间歇性导管，Rusch MMG 亲水间歇性导管

查看所有 19 个设备 →

官方来源

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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。