FDA 510(k)

HANAROSTENT 低轴结肠/直肠 (NNN), HANAROSTENT 低轴十二指肠/幽门 (NNN)

K号: K183616 · 2019-01-10

决定日期2019-01-10

产品代码MQR

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决定实质等同

器械摘要

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) is the device name listed in this FDA 510(k) record. The listed applicant is M.I.Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K183616. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)?

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K183616.

When did HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) receive FDA 510(k) clearance?

HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) received FDA 510(k) clearance on 2019-01-10, under 510(k) number K183616.

Who is the listed applicant for HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)?

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

What is the FDA product code for HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)?

The FDA product code for HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) is MQR.

列明M.I.Tech 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。

K253327HANAROSTENT 食管上段 (CCC)K213251HANAROSTENT 食管非对称 (CCC)K201160HANAROSTENT 食管 (CCC), HANAROSTENT 食管 (NCN)K202973HANAROSTENT Benefit Biliary (NNN)K201342HANAROSTENT 气管/支气管 (CCC)K200860HANAROSTENT 食管TTS (CCC), HANAROSTENT 食管TTS (NCN)

查看所有 11 个设备 →

相关器械（代码：MQR）

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。

K234046WallFlex 结肠支架系统带锚定锁输送系统；WallFlex 十二指肠支架系统带锚定锁输送系统；WallFlex 结肠软支架系统带锚定锁输送系统；WallFlex 十二指肠软支架系统带锚定锁输送系统Boston Scientific Corporation K201159WallFlex 结肠支架系统带锚定锁输送系统Boston Scientific Corporation K200257WallFlex 结肠软支架系统，配备锚定锁输送系统，WallFlex 十二指肠软支架系统，配备锚定锁输送系统Boston Scientific Corporation K190141HANAROSTENT 低轴结肠/直肠 (NNN)M.I.Tech Co., Ltd.K180180HANAROSTENT 低轴TM 结肠/直肠 (NNN), HANAROSTENT 低轴TM 十二指肠/幽门 (NNN)M.I.Tech Co., Ltd.

官方来源

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