食管TTS支架
K号: K240522 · 2024-03-22
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器械摘要
Esophageal TTS Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K240522. 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 2024-03-22. The listed applicant is Taewoong Medical. The 510(k) number is K240522.
When did Esophageal TTS Stent receive FDA 510(k) clearance?
Esophageal TTS Stent received FDA 510(k) clearance on 2024-03-22, under 510(k) number K240522.
Who is the listed applicant for Esophageal TTS Stent?
The FDA 510(k) record lists Taewoong Medical 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。
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。
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