FDA 510(k)

CARTO™ 3 EP 导航系统 V9.0 with PIU Plus

K号: K254085 · 2026-01-18

决定日期2026-01-18

产品代码DQK

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

CARTO™ 3 EP Navigation System V9.0 with PIU Plus 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 2026-01-18 under 510(k) number K254085. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CARTO™ 3 EP Navigation System V9.0 with PIU Plus?

CARTO™ 3 EP Navigation System V9.0 with PIU Plus is a medical device that received FDA 510(k) clearance on 2026-01-18. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K254085.

When did CARTO™ 3 EP Navigation System V9.0 with PIU Plus receive FDA 510(k) clearance?

CARTO™ 3 EP Navigation System V9.0 with PIU Plus received FDA 510(k) clearance on 2026-01-18, under 510(k) number K254085.

Who is the listed applicant for CARTO™ 3 EP Navigation System V9.0 with PIU Plus?

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 CARTO™ 3 EP Navigation System V9.0 with PIU Plus?

The FDA product code for CARTO™ 3 EP Navigation System V9.0 with PIU Plus is DQK.

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。

K252972CARTO™ 3 EP 导航系统 V8.4 K252302CARTO™ 3 EP 导航系统 V8.1 K241540NUVISION® 超声导管；NUVISION® NAV 超声导管 K240050SOUNDSTAR® CRYSTAL 超声导管 K231207CARTO™ 3 EP 导航系统软件 V8.0（FG-5400-00，FG-5400-00U）K231312PENTARAY® NAV ECO高密度测绘导管，DECANAV®测绘导管，Webster® CS导管带自动ID，Webster® CS导管带EZ Steer技术，Webster® CS导管带EZ Steer技术与自动ID

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官方来源

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