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LHI

Set, I.V. Fluid Transfer

产品代码
LHI
器械名称
Set, I.V. Fluid Transfer
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 880.5440
FDA 专业组
General Hospital
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
20 件
其中 Summary 已存档
17 份,可直接下载
FDA 历史累计 510(k)
206 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(20 件)

数据窗口为最近三年。最新一件:2026-06-12。

510(k) 号批准日期申请人器械名称摘要
K2529872026-06-12Epic Medical Pte. , Ltd.ADRx™ Admixture DevicePDF
K2603012026-06-05Hangzhou Qiantang Longyue Biotechnolog…Vial AdapterPDF
K2503452025-10-24Medline Industries, LPMedline Bag DecanterPDF
K2517152025-10-14Asset MedikalFlowArt® Vial Access Device Vented—
K2516762025-09-16Microtek Medical, LLCMedline Microtek C-Flo Bag Decanter, Sterile (2000S)…PDF
K2434042025-07-18Takeda PharmaceuticalsHyHub™ and HyHub™ Duo Vial Access DevicesPDF
K2407612025-03-21Yukon Medical, LLCArisure® Closed Male Luer with Spike Adapter (YM060)PDF
K2439852025-01-22Icu Medical, Inc.Rio™ Drug Reconstitution Transfer DevicePDF
K2434862024-12-06Yukon Medical, LLCSmartSiteTM Vented Vial Access DevicePDF
K2419762024-09-06Sfm Medical Devices GmbHnextaro® va, 15mm, 5µmPDF
K2332872024-07-26Hangzhou Qiantang Longyue Biotechnolog…Vent Vial AdapterPDF
K2329872024-06-26Asset Medikal Tasarim Sanayi VE Ticare…FlowArt Valve for Vial Access—
K2409402024-05-03West Pharmaceutical Services, Inc.Vial2Bag Advanced® 20mm Admixture DeviceFDA
K2332842024-05-01Hangzhou Qiantang Longyue Biotechnolog…Vial Adapter with FilterPDF
K2407482024-04-16Sfm Medical Devices GmbHnextaro® v, 20/20PDF
K2330212024-03-06Care FusionBD SmartSite™ 13mm Vial Access Device; BD SmartSite™…PDF
K2310712024-01-19West Pharma. Services IL, Ltd.Mix2Vial® Transfer DevicePDF
K2328752023-12-14West Pharma. Services IL, Ltd.Vial Adapter 20mmPDF
K2309882023-12-01West Pharma. Services IL, Ltd.Vial2Bag Advanced® 13mm Admixture DevicePDF
K2320552023-10-06Shanghai Lingfu Technology Co., Ltd.Vial AdapterPDF

其中 17 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: LHI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。