FDA 510(k)

OPTRELL™ Mapping 导管 TRUEref™ 技术

K号: K230253 · 2023-03-02

决定日期2023-03-02

产品代码MTD

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

OPTRELL™ Mapping Catheter with TRUEref™ Technology is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K230253. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OPTRELL™ Mapping Catheter with TRUEref™ Technology?

OPTRELL™ Mapping Catheter with TRUEref™ Technology is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K230253.

When did OPTRELL™ Mapping Catheter with TRUEref™ Technology receive FDA 510(k) clearance?

OPTRELL™ Mapping Catheter with TRUEref™ Technology received FDA 510(k) clearance on 2023-03-02, under 510(k) number K230253.

Who is the listed applicant for OPTRELL™ Mapping Catheter with TRUEref™ Technology?

The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTRELL™ Mapping Catheter with TRUEref™ Technology?

The FDA product code for OPTRELL™ Mapping Catheter with TRUEref™ Technology is MTD.

列明Biosense Webster, 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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官方来源

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