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FDA 510(k)

Turnpike 导管；Turnpike 螺旋导管；Turnpike 金导管；Turnpike LP 导管

K号: K191560 · 2019-08-09

申请人Vascular Solutions, LLC
决定日期2019-08-09
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

Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K191560. 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 Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter?

Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K191560.

When did Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter receive FDA 510(k) clearance?

Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter received FDA 510(k) clearance on 2019-08-09, under 510(k) number K191560.

Who is the listed applicant for Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter?

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

What is the FDA product code for Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter?

The FDA product code for Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter is DQY.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Vascular Solutions, 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。

K233729Ringer 灌注球囊导管，2.00 x 20mm (5881)；Ringer 灌注球囊导管，2.50 x 20mm (5882)；Ringer 灌注球囊导管，2.50 x 30mm (5883)；Ringer 灌注球囊导管，3.00 x 20mm (5884)；Ringer 灌注球囊导管，3.00 x 30mm (5885)；Ringer 灌注球囊导管，3.50 x 20mm (5886)；Ringer 灌注球囊导管，3.50 x 30mm (5887)；Ringer 灌注球囊导管，4.00 x 20mm (5888)；Ringer 灌注球囊导管，4.00 x 30mm (58)K230637瓦特森临时起搏导丝（2250）K220647GuideLiner Coast，5.5F（5270）；GuideLiner Coast，6F（5271）；GuideLiner Coast，7F（5272）；GuideLiner Coast，8F（5273）K221470Langston 双腔导管K212211Turnpike 导管，Turnpike 螺旋导管，Turnpike LP 导管，Turnpike 金导管，GuideLiner V3 导管，TrapLiner 导管K212167R350 导丝，Spectre 导丝，Raider 导丝，Bandit 导丝，Warrior 导丝

查看所有 11 个设备 →

相关器械（代码：DQY）

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。

K262817CrossFAST集成微导管高级输送系统Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 快速导丝Alembic, LLCK262240SSPC NXT 输送导管CenterPoint Systems, LLCK261766CPS 定位器 3D Plus 输送导管CenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP 导管Abbott

官方来源

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