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FDA 510(k)

SafeCross经隔膜穿刺和引入（TSP/I）系统

K号: K203459 · 2021-07-06

申请人East End Medical I, LLC
决定日期2021-07-06
产品代码DYB
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

SafeCross Transseptal Puncture and Introducer (TSP/I) System is the device name listed in this FDA 510(k) record. The listed applicant is East End Medical I, LLC. It received FDA 510(k) clearance on 2021-07-06 under 510(k) number K203459. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SafeCross Transseptal Puncture and Introducer (TSP/I) System?

SafeCross Transseptal Puncture and Introducer (TSP/I) System is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is East End Medical I, LLC. The 510(k) number is K203459.

When did SafeCross Transseptal Puncture and Introducer (TSP/I) System receive FDA 510(k) clearance?

SafeCross Transseptal Puncture and Introducer (TSP/I) System received FDA 510(k) clearance on 2021-07-06, under 510(k) number K203459.

Who is the listed applicant for SafeCross Transseptal Puncture and Introducer (TSP/I) System?

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

What is the FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System?

The FDA product code for SafeCross Transseptal Puncture and Introducer (TSP/I) System is DYB.

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East End Medical I, 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。

K240600SafeCross血管引入系统（4001）

相关器械（代码：DYB）

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。

K253526NAMIC 扩张器和套管Medline Industries, LPK261529微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（SIS05C）；微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（IS01）；引导器套件/微引导器套件/引导器套装/微引导器套装/微引导器鞘套装/引导器鞘套装（NIS04）Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line 可撕开引导器Health Line International CorporationK261492FieldFlex 可弯曲鞘CenterPoint Systems, LLCK260606Echo 大口径引导鞘Echo Medical, LLC

官方来源

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