FDA 510(k)

HANAROSTENT 气管/支气管 (CCC)

K号: K201342 · 2020-12-31

决定日期2020-12-31

产品代码JCT

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决定实质等同

器械摘要

HANAROSTENT Trachea/Bronchium (CCC) 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 2020-12-31 under 510(k) number K201342. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HANAROSTENT Trachea/Bronchium (CCC)?

HANAROSTENT Trachea/Bronchium (CCC) is a medical device that received FDA 510(k) clearance on 2020-12-31. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K201342.

When did HANAROSTENT Trachea/Bronchium (CCC) receive FDA 510(k) clearance?

HANAROSTENT Trachea/Bronchium (CCC) received FDA 510(k) clearance on 2020-12-31, under 510(k) number K201342.

Who is the listed applicant for HANAROSTENT Trachea/Bronchium (CCC)?

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 Trachea/Bronchium (CCC)?

The FDA product code for HANAROSTENT Trachea/Bronchium (CCC) is JCT.

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)K200860HANAROSTENT 食管TTS (CCC), HANAROSTENT 食管TTS (NCN)K190141HANAROSTENT 低轴结肠/直肠 (NNN)

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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。