FDA 510(k)

ExpanSure 经房间隔扩张系统

K号: K182064 · 2019-03-21

决定日期2019-03-21

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： --- 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

ExpanSure Transseptal Dilation System 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 2019-03-21 under 510(k) number K182064. 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 ExpanSure Transseptal Dilation System?

ExpanSure Transseptal Dilation System is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K182064.

When did ExpanSure Transseptal Dilation System receive FDA 510(k) clearance?

ExpanSure Transseptal Dilation System received FDA 510(k) clearance on 2019-03-21, under 510(k) number K182064.

Who is the listed applicant for ExpanSure Transseptal Dilation System?

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 ExpanSure Transseptal Dilation System?

The FDA product code for ExpanSure Transseptal Dilation System is DRE.

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。

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