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FDA 510(k)

Pruitt F3 颈动脉分流器，10 Fr，Pruitt F3 颈动脉分流器，9 Fr，Pruitt F3 颈动脉分流器，8 Fr

K号: K182916 · 2018-11-16

申请人Lemaitre Vascular
决定日期2018-11-16
产品代码MJN
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

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Lemaitre Vascular. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182916. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Lemaitre Vascular. The 510(k) number is K182916.

When did Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr receive FDA 510(k) clearance?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182916.

Who is the listed applicant for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

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

What is the FDA product code for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

The FDA product code for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is MJN.

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Lemaitre 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。

K190882XenoSure 生物贴片K190267EZE SIT 瓣膜刀

相关器械（代码：MJN）

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。

K243795pREBOA-PRO 导管Prytime Medical Devices, Inc.K251358Bridge Plus 阻塞气球 (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA 阻塞系统Abiomed, Inc.K214060LANDMARK REBOA 导管Zien Medical Technologies, Inc.K211610Fogarty 阻塞导管Edwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

官方来源

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