FDA 510(k)

Clear-Jet注射导管

K号: K181690 · 2018-12-21

决定日期2018-12-21

产品代码FBK

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决定实质等同

器械摘要

Clear-Jet Injection Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K181690. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Clear-Jet Injection Catheter?

Clear-Jet Injection Catheter is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K181690.

When did Clear-Jet Injection Catheter receive FDA 510(k) clearance?

Clear-Jet Injection Catheter received FDA 510(k) clearance on 2018-12-21, under 510(k) number K181690.

Who is the listed applicant for Clear-Jet Injection Catheter?

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

What is the FDA product code for Clear-Jet Injection Catheter?

The FDA product code for Clear-Jet Injection Catheter is FBK.

列明Finemedix Co., Ltd.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。

K251478ClearTip TBNA 类型 K250994ClearTip FNA 和 FNB 类型 K242857ClearHemograsper K242134ClearCap远端附件 K231267ClearTip K202616ClearCap远端附件

查看所有 11 个设备 →

相关器械（代码：FBK）

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。

官方来源

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