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FDA 510(k)

Advcare Vial Direct to Bag (VDB) 无针混合装置

K号: K212525 · 2022-08-19

申请人Advcare Medical
决定日期2022-08-19
产品代码LHI
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is the device name listed in this FDA 510(k) record. The listed applicant is Advcare Medical. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K212525. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Advcare Medical. The 510(k) number is K212525.

When did Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices receive FDA 510(k) clearance?

Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices received FDA 510(k) clearance on 2022-08-19, under 510(k) number K212525.

Who is the listed applicant for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

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

What is the FDA product code for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices?

The FDA product code for Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices is LHI.

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：LHI）

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。

K252987ADRx® 混合设备Epic Medical Pte. , Ltd.K260301药瓶适配器Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline 袋式过滤器Medline Industries, LPK251715FlowArt® 安瓿瓶接入通风装置Asset MedikalK251676Medline Microtek C-Flo 瓶式过滤器，无菌（2000S）；Medline Microtek 瓶式过滤器 II，无菌（2002S）；Medline Microtek 瓶式过滤器，无菌（2006S）；Medline Microtek 转移装置，无菌（2008S）Microtek Medical, LLCK243404HyHub™ 和 HyHub™ Duo 瓶盖访问设备Takeda Pharmaceuticals

官方来源

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