FDA 510(k)

CARTO™ 3 EP 导航系统软件 V8.0（FG-5400-00，FG-5400-00U）

K号: K231207 · 2023-09-07

决定日期2023-09-07

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 Software V8.0 (FG-5400-00, FG-5400-00U) 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 2023-09-07 under 510(k) number K231207. 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 Software V8.0 (FG-5400-00, FG-5400-00U)?

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K231207.

When did CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) receive FDA 510(k) clearance?

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231207.

Who is the listed applicant for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)?

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 Software V8.0 (FG-5400-00, FG-5400-00U)?

The FDA product code for CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) 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 K254085CARTO™ 3 EP 导航系统 V9.0 with PIU Plus 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 K231412CARTO VIZIGO® 8.5F 双向引导鞘（D-1385-01-S，D-1385-02-S，D-1385-03-S）

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官方来源

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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。