FDA 510(k)

Duo-Flow 侧侧双腔导管

K号: K192807 · 2020-04-23

申请人Medical Components, Inc. (dba MedComp)

决定日期2020-04-23

产品代码MPB

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决定实质等同

器械摘要

Duo-Flow Side x Side Double 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 2020-04-23 under 510(k) number K192807. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Duo-Flow Side x Side Double Lumen Catheter?

Duo-Flow Side x Side Double Lumen Catheter is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Medical Components, Inc. (dba MedComp). The 510(k) number is K192807.

When did Duo-Flow Side x Side Double Lumen Catheter receive FDA 510(k) clearance?

Duo-Flow Side x Side Double Lumen Catheter received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192807.

Who is the listed applicant for Duo-Flow Side x Side Double 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 Duo-Flow Side x Side Double Lumen Catheter?

The FDA product code for Duo-Flow Side x Side Double Lumen Catheter is MPB.

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。

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