FDA 510(k)

12F 三通流三腔导管

K号: K181175 · 2018-07-05

申请人Medical Components, Inc. (dba MedComp)

决定日期2018-07-05

产品代码NIE

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定Unknown

器械摘要

12F Tri-Flow Triple Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc. (dba MedComp). It received FDA 510(k) clearance on 2018-07-05 under 510(k) number K181175. The device is classified under product code NIE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the 12F Tri-Flow Triple Lumen Catheter?

12F Tri-Flow Triple Lumen Catheter is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K181175.

When did 12F Tri-Flow Triple Lumen Catheter receive FDA 510(k) clearance?

12F Tri-Flow Triple Lumen Catheter received FDA 510(k) clearance on 2018-07-05, under 510(k) number K181175.

Who is the listed applicant for 12F Tri-Flow Triple Lumen Catheter?

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

What is the FDA product code for 12F Tri-Flow Triple Lumen Catheter?

The FDA product code for 12F Tri-Flow Triple Lumen Catheter is NIE.

列明Medical Components, Inc. (dba MedComp)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。

K232945Trio-CT® 三腔导管带弯曲延长件 K202176Symetrex LTHD 导管，Symetrex LTHD 导管带侧孔 K192807Duo-Flow 侧侧双腔导管 K183219三联CT三腔导管 K17366715.5F X 19 cm Symetrex 长期血液透析导管带侧孔，15.5F X 23 cm Symetrex 长期血液透析导管带侧孔，15.5F X 28 cm Symetrex 长期血液透析导管带侧孔，15.5F X 33 cm Symetrex 长期血液透析导管带侧孔，15.5F X 37 cm Symetrex 长期血液透析导管带侧孔 K180567C3 波系统

查看所有 9 个设备 →

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。