FDA 510(k)

三联CT三腔导管

K号: K183219 · 2019-06-14

申请人Medical Components, Inc. (dba MedComp)

决定日期2019-06-14

产品代码NIE

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决定Unknown

器械摘要

Trio-CT 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 2019-06-14 under 510(k) number K183219. 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 Trio-CT Triple Lumen Catheter?

Trio-CT Triple Lumen Catheter is a medical device that received FDA 510(k) clearance on 2019-06-14. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K183219.

When did Trio-CT Triple Lumen Catheter receive FDA 510(k) clearance?

Trio-CT Triple Lumen Catheter received FDA 510(k) clearance on 2019-06-14, under 510(k) number K183219.

Who is the listed applicant for Trio-CT 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 Trio-CT Triple Lumen Catheter?

The FDA product code for Trio-CT 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 K18117512F 三通流三腔导管 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

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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。