FDA 510(k)

VeriSight 心脏内超声心动图导管（VSICE2D）；VeriSight Pro 心脏内超声心动图导管（VSICE3D）

K号: K251103 · 2025-05-09

申请人Philips Image Guided Therapy Corporation

决定日期2025-05-09

产品代码OBJ

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

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K251103. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K251103.

When did VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) receive FDA 510(k) clearance?

VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) received FDA 510(k) clearance on 2025-05-09, under 510(k) number K251103.

Who is the listed applicant for VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

The FDA 510(k) record lists Philips Image Guided Therapy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)?

The FDA product code for VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) is OBJ.

列明Philips Image Guided Therapy Corporation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。

K253714IntraSight Plus K200812VeriSight 心脏内超声心动图（ICE）导管，VeriSight Pro ICE 导管 K200410Reconnaissance PV .018 OTW 数字IVUS导管

相关器械（代码：OBJ）

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。

官方来源

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