超级套管
K号: K200379 · 2020-03-19
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决定日期2020-03-19
产品代码DRE
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
---
请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
Super Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K200379. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Super Sheath?
Super Sheath is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K200379.
When did Super Sheath receive FDA 510(k) clearance?
Super Sheath received FDA 510(k) clearance on 2020-03-19, under 510(k) number K200379.
Who is the listed applicant for Super Sheath?
The FDA 510(k) record lists Togo Medikit Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Super Sheath?
The FDA product code for Super Sheath is DRE.
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Togo Medikit 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：DRE）
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。
K261310FlexTract 可弯曲-旋转扩张导管鞘套装Merit Medical Systems, Inc.K253616ProtekDilate 血管通路套件Sorin Group Italia S.R.L.K251325VersaCross Connect™ 腱间扩张器Baylis Medical Company, Inc.K242229Micro Ace Gold 高级微接入系统Merit Medical Systems, Inc.K241720VersaCross Connect™ 腱间扩张器Baylis Medical Company, Inc.K233647VersaCross Connect™ 腱间扩张器Baylis Medical Company, Inc.
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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