维雅特克14 Plus 周围血管扩张导管
K号: K221057 · 2022-05-05
广告
决定日期2022-05-05
产品代码LIT
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
Viatrac 14 Plus Peripheral 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 2022-05-05 under 510(k) number K221057. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Viatrac 14 Plus Peripheral Dilatation Catheter?
Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Abbott Vascular. The 510(k) number is K221057.
When did Viatrac 14 Plus Peripheral Dilatation Catheter receive FDA 510(k) clearance?
Viatrac 14 Plus Peripheral Dilatation Catheter received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221057.
Who is the listed applicant for Viatrac 14 Plus Peripheral 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 Viatrac 14 Plus Peripheral Dilatation Catheter?
The FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter is LIT.
相关临床试验
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。
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。
K220634NC TREK NEO冠状动脉扩张导管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 WiresK180040NC 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
相关器械（代码：LIT）
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。
K260416ZYLOX 鸭嘴兽 PTA 扩张球囊导管Zylox Medtech Co., Ltd.K254212NC PTA球囊扩张导管Kossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA球囊导管WAVE Medical AGK252512Armada™ 14 NC PTA 导管ABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035导管Natec Medical , Ltd.K250706Passeo-35 Xeo 周围血管扩张导管；Passeo-18 周围血管扩张导管；Passeo-14 周围血管扩张导管；Oscar 多功能导管系统；Pantera Pro 经皮腔内冠状动脉成形术导管；Pantera LEO 经皮腔内冠状动脉成形术（PTCA）导管Biotronik, Inc.
官方来源
在 FDA 数据库中查看 →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。
广告