FDA 510(k)

CT中线

K号: K170770 · 2017-07-25

申请人Medical Components, Inc. (dba MedComp)

决定日期2017-07-25

产品代码PND

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

CT Midline 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 2017-07-25 under 510(k) number K170770. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CT Midline?

CT Midline is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K170770.

When did CT Midline receive FDA 510(k) clearance?

CT Midline received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170770.

Who is the listed applicant for CT Midline?

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 CT Midline?

The FDA product code for CT Midline is PND.

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 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

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。