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FDA 510(k)

Alpha Control Liner System (ACLS)

K号: K223738 · 2023-01-11

申请人Coapt
决定日期2023-01-11
产品代码GXY
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Alpha Control Liner System (ACLS) is the device name listed in this FDA 510(k) record. The listed applicant is Coapt. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K223738. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alpha Control Liner System (ACLS)?

Alpha Control Liner System (ACLS) is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Coapt. The 510(k) number is K223738.

When did Alpha Control Liner System (ACLS) receive FDA 510(k) clearance?

Alpha Control Liner System (ACLS) received FDA 510(k) clearance on 2023-01-11, under 510(k) number K223738.

Who is the listed applicant for Alpha Control Liner System (ACLS)?

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

What is the FDA product code for Alpha Control Liner System (ACLS)?

The FDA product code for Alpha Control Liner System (ACLS) is GXY.

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Coapt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。

K223605ControlSeal 电极 (ELSB)

相关器械（代码：GXY）

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。

K262654Dexus假肢系统（MSL2，MSR2）Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM 杯 MRI/CT（型号 72704/21US，72704/23US，72704/25US，72704/27US）Ambu® NeurolineTM 杯 MRI/CT套装（型号 72704/21-1010US，72704/21-1010US，72704/23-1010US，72704/25-1010US，72704/27-1010US）Ambu® NeurolineTM 杯 MRI/CT迷你套装（型号 72704/21-0301US，72704/23-0301US，72704/25-0301US，72704/27-0301US）Ambu A/SK261442Charlotte ACC25 表面电极阵列；Charlotte ACC25 可重复使用表面电极阵列Cadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde 医疗电极（T5/ 5cm x 5cm 电极 T10/ 5cm x 10cm 电极）Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR 条件杯电极Technomed Europe

官方来源

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