食管TTS支架
K号: K221482 · 2022-06-22
广告
决定日期2022-06-22
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
Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K221482. 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 Esophageal TTS Stent?
Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K221482.
When did Esophageal TTS Stent receive FDA 510(k) clearance?
Esophageal TTS Stent received FDA 510(k) clearance on 2022-06-22, under 510(k) number K221482.
Who is the listed applicant for Esophageal TTS Stent?
The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Esophageal TTS Stent?
The FDA product code for Esophageal TTS Stent 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Taewoong Medical 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 CorporationK253327HANAROSTENT 食管上段 (CCC)M.I.Tech Co., Ltd.K243619Niti-S 食管支架; 食管 TTS 支架Taewoong Medical 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