FDA 510(k)

FlexiGo 3D 输送导管

K号: K250492 · 2025-06-18

决定日期2025-06-18

产品代码DQY

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

FlexiGo 3D Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K250492. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FlexiGo 3D Delivery Catheter?

FlexiGo 3D Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is CenterPoint Systems, LLC. The 510(k) number is K250492.

When did FlexiGo 3D Delivery Catheter receive FDA 510(k) clearance?

FlexiGo 3D Delivery Catheter received FDA 510(k) clearance on 2025-06-18, under 510(k) number K250492.

Who is the listed applicant for FlexiGo 3D Delivery Catheter?

FDA 510(k)记录中列出CenterPoint Systems, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for FlexiGo 3D Delivery Catheter?

The FDA product code for FlexiGo 3D Delivery Catheter is DQY.

列明CenterPoint Systems, LLC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。

K261766CPS 定位器 3D Plus 输送导管 K262240SSPC NXT 输送导管 K261492FieldFlex 可弯曲鞘 K260942AuST 可弯曲鞘 K260163AuST CSP 引导器 K250828CPS 定位器 3D Plus 输送导管

查看所有 15 个设备 →

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。