HANAROSTENT 食管非对称 (CCC)
K号: K213251 · 2021-11-18
广告
决定日期2021-11-18
产品代码ESW
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
HANAROSTENT Esophagus Asymmetric (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 2021-11-18 under 510(k) number K213251. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the HANAROSTENT Esophagus Asymmetric (CCC)?
HANAROSTENT Esophagus Asymmetric (CCC) is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is M.I.Tech Co., Ltd.. The 510(k) number is K213251.
When did HANAROSTENT Esophagus Asymmetric (CCC) receive FDA 510(k) clearance?
HANAROSTENT Esophagus Asymmetric (CCC) received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213251.
Who is the listed applicant for HANAROSTENT Esophagus Asymmetric (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 Esophagus Asymmetric (CCC)?
The FDA product code for HANAROSTENT Esophagus Asymmetric (CCC) is ESW.
相关临床试验
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。
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。
相关器械（代码：ESW）
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。
K261978WallFlex 胃食管支架系统；Agile 胃食管导丝（OTW）支架系统Boston Scientific CorporationK243619Niti-S 食管支架; 食管 TTS 支架Taewoong Medical Co., Ltd.K253327HANAROSTENT 食管上段 (CCC)M.I.Tech Co., Ltd.K251265Resilience 完全覆盖食管支架系统Merit Medical Systems, Inc.K233939Ultraflex 食管 NG 支架系统；WallFlex 食管支架系统Boston ScientificK233837Agile Esophageal Stent SystemBoston Scientific Corporation
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。
广告