FDA 510(k)

Gentuity® HF-OCT 成像系统，配备 Vis-Rx Prime® 微成像导管

K号: K242966 · 2025-01-31

决定日期2025-01-31

产品代码DQO

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

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Gentuity, LLC. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K242966. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter?

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Gentuity, LLC. The 510(k) number is K242966.

When did Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter receive FDA 510(k) clearance?

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter received FDA 510(k) clearance on 2025-01-31, under 510(k) number K242966.

Who is the listed applicant for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter?

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

What is the FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter?

The FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is DQO.

列明Gentuity, 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。

K242239HF-OCT 成像系统与 Vis-RX 微成像导管（G10（HF-OCT 控制台），G30（Vis-Rx 微成像导管））K230620Gentuity® HF-OCT 成像系统，配备 Vis-Rx® 微成像导管 K192922Gentuity HF-OCT 成像系统，配备 Vis-Rx 微成像导管

相关器械（代码：DQO）

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。

K261455动脉压力监测套装/托盘Spectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N)Bioptimal International Pte. , Ltd.K254278动脉压力监测套装/托盘Spectrum Vascular K250751DualView导管Terumo Corporation K242420pNOVUS 21 微导管Phenox, Ltd.K233268Impress 血管造影导管Merit Medical Systems, Inc.

官方来源

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