VersaCross Connect™ 腱间扩张器
K号: K233647 · 2023-12-14
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决定日期2023-12-14
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]
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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
VersaCross Connect™ Transseptal Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K233647. 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 VersaCross Connect™ Transseptal Dilator?
VersaCross Connect™ Transseptal Dilator is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K233647.
When did VersaCross Connect™ Transseptal Dilator receive FDA 510(k) clearance?
VersaCross Connect™ Transseptal Dilator received FDA 510(k) clearance on 2023-12-14, under 510(k) number K233647.
Who is the listed applicant for VersaCross Connect™ Transseptal Dilator?
The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VersaCross Connect™ Transseptal Dilator?
The FDA product code for VersaCross Connect™ Transseptal Dilator 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Baylis Medical Company, Inc.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.K232609Micro Ace™ 高级微接入系统Merit Medical Systems, 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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