LHI
- 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)
- 206 件
该代码近三年的 510(k)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K252987 | 2026-06-12 | Epic Medical Pte. , Ltd. | ADRx Admixture Device 摘要 |
| K260301 | 2026-06-05 | Hangzhou Qiantang Longyue Biotechnolog | Vial Adapter 摘要 |
| K250345 | 2025-10-24 | Medline Industries, LP | Medline Bag Decanter 摘要 |
| K251715 | 2025-10-14 | Asset Medikal | FlowArt® Vial Access Device Vented |
| K251676 | 2025-09-16 | Microtek Medical, LLC | Medline Microtek C-Flo Bag Decanter, Sterile (2000S) 摘要 |
| K243404 | 2025-07-18 | Takeda Pharmaceuticals | HyHub and HyHub Duo Vial Access Devices 摘要 |
| K240761 | 2025-03-21 | Yukon Medical, LLC | Arisure® Closed Male Luer with Spike Adapter (YM060) 摘要 |
| K243985 | 2025-01-22 | Icu Medical, Inc. | Rio Drug Reconstitution Transfer Device 摘要 |
| K243486 | 2024-12-06 | Yukon Medical, LLC | SmartSiteTM Vented Vial Access Device 摘要 |
| K241976 | 2024-09-06 | Sfm Medical Devices GmbH | nextaro® va, 15mm, 5µm 摘要 |
| K233287 | 2024-07-26 | Hangzhou Qiantang Longyue Biotechnolog | Vent Vial Adapter 摘要 |
| K232987 | 2024-06-26 | Asset Medikal Tasarim Sanayi VE Ticare | FlowArt Valve for Vial Access |
| K240940 | 2024-05-03 | West Pharmaceutical Services, Inc. | Vial2Bag Advanced® 20mm Admixture Device 摘要 |
| K233284 | 2024-05-01 | Hangzhou Qiantang Longyue Biotechnolog | Vial Adapter with Filter 摘要 |
| K240748 | 2024-04-16 | Sfm Medical Devices GmbH | nextaro® v, 20/20 摘要 |
| K233021 | 2024-03-06 | Care Fusion | BD SmartSite 13mm Vial Access Device; BD SmartSite 摘要 |
| K231071 | 2024-01-19 | West Pharma. Services IL, Ltd. | Mix2Vial® Transfer Device 摘要 |
| K232875 | 2023-12-14 | West Pharma. Services IL, Ltd. | Vial Adapter 20mm 摘要 |
| K230988 | 2023-12-01 | West Pharma. Services IL, Ltd. | Vial2Bag Advanced® 13mm Admixture Device 摘要 |
| K232055 | 2023-10-06 | Shanghai Lingfu Technology Co., Ltd. | Vial Adapter 摘要 |
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。