FDA 510(k)

NC TREK NEO冠状动脉扩张导管

K号: K220634 · 2022-06-30

决定日期2022-06-30

产品代码LOX

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

NC TREK NEO Coronary Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K220634. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NC TREK NEO Coronary Dilatation Catheter?

NC TREK NEO Coronary Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Abbott Vascular. The 510(k) number is K220634.

When did NC TREK NEO Coronary Dilatation Catheter receive FDA 510(k) clearance?

NC TREK NEO Coronary Dilatation Catheter received FDA 510(k) clearance on 2022-06-30, under 510(k) number K220634.

Who is the listed applicant for NC TREK NEO Coronary Dilatation Catheter?

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

What is the FDA product code for NC TREK NEO Coronary Dilatation Catheter?

The FDA product code for NC TREK NEO Coronary Dilatation Catheter is LOX.

列明Abbott Vascular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。

K221057维雅特克14 Plus 周围血管扩张导管 K201834HI-TORQUE PROCEED 导丝系列 K200144HI-TORQUE 钢芯裸导丝 K193126HI-TORQUE InfilTrac 导丝系列 K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires K180040NC TREK® RX冠状动脉扩张导管；NC TREK® OTW冠状动脉扩张导管；TREK® RX冠状动脉扩张导管；TREK® OTW冠状动脉扩张导管；MINI TREK® RX冠状动脉扩张导管；MINI TREK® OTW冠状动脉扩张导管；MINI TREK® II OTW冠状动脉扩张导管

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官方来源

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