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FDA 510(k)

腹部主动脉和连接处止血带 - 稳定型 (AAJT-S)

K号: K221661 · 2023-03-03

申请人Compression Works, Inc.
决定日期2023-03-03
产品代码DXC
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

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is the device name listed in this FDA 510(k) record. The listed applicant is Compression Works, Inc.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K221661. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Compression Works, Inc.. The 510(k) number is K221661.

When did Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) receive FDA 510(k) clearance?

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) received FDA 510(k) clearance on 2023-03-03, under 510(k) number K221661.

Who is the listed applicant for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

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

What is the FDA product code for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)?

The FDA product code for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is DXC.

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：DXC）

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。

K262086PreludeSYNC™ 肘部压缩装置Merit Medical Systems, Inc.K260105Fogarty 弹簧夹，无手柄夹具和夹具插入物Edwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060救命止血带TW MedicalK243627喉镜接头动脉限制夹（L-ARC）；动脉限制夹（ARC）Arc Trauma, LLCK253070Namic径向臂带，23厘米（DYNJRADBAND）；Namic径向臂带，26厘米（DYNJRADBANDL）Medline Industries, LP

官方来源

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