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FDA 510(k)

MEDRON 血管扩张器 - 6F x 22cm HDPE 扩张器，MEDRON 血管扩张器 - 15.5F - 17.5F HDPE 扩张器

K号: K192283 · 2020-05-06

申请人Medron, LLC
决定日期2020-05-06
产品代码DRE
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

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Medron, LLC. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K192283. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is a medical device that received FDA 510(k) clearance on 2020-05-06. The listed applicant is Medron, LLC. The 510(k) number is K192283.

When did MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator receive FDA 510(k) clearance?

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator received FDA 510(k) clearance on 2020-05-06, under 510(k) number K192283.

Who is the listed applicant for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

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

What is the FDA product code for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator?

The FDA product code for MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator is DRE.

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

相关器械（代码：DRE）

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。

K261310FlexTract 可弯曲-旋转扩张导管鞘套装Merit Medical Systems, Inc.K253616ProtekDilate 血管通路套件Sorin Group Italia S.R.L.K251325VersaCross Connect™ 腱间扩张器Baylis Medical Company, Inc.K242229Micro Ace Gold 高级微接入系统Merit Medical Systems, Inc.K241720VersaCross Connect™ 腱间扩张器Baylis Medical Company, Inc.K233647VersaCross Connect™ 腱间扩张器Baylis Medical Company, Inc.

官方来源

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