FPA
- 产品代码
- FPA
- 器械名称
- Set, Administration, Intravascular
- 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)
- 1174 件
该代码近三年的 510(k)（24 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261530 | 2026-06-03 | Deka Research and Development | iiSure Infusion Set 摘要 |
| K252543 | 2026-05-04 | Amsino International, Inc. | AMSafe Administration Set (BA-70075, BA-70071-D, BA- 摘要 |
| K251375 | 2026-02-12 | Puracath Medical, Inc. | PuraCath Firefly Needleless Connector IT (9005) 摘要 |
| K251257 | 2025-12-04 | Np Medical | nSet+ Stabilization Set [6426733]; nSet+ Stabilizati 摘要 |
| K250325 | 2025-10-30 | Carefusion (Bd) | BD Alaris Pump Infusion Set 摘要 |
| K251814 | 2025-08-29 | Epic Medical Pte. , Ltd. | EZ IV Administration Set 摘要 |
| K251854 | 2025-08-06 | Tandem Diabetes Care | SteadiSet infusion set 摘要 |
| K243841 | 2025-08-01 | Deka Research and Development | Sparta Infusion Set for Insulin 摘要 |
| K243392 | 2025-07-24 | B.Braun Medical, Inc. | Infusomat® Space Volumetric Infusion Pump Administra 摘要 |
| K250616 | 2025-06-05 | Icu Medical, Inc. | Clave Neutral-Displacement Needlefree Connectors 摘要 |
| K242692 | 2025-05-09 | Capillary Biomedical, LLC | SteadiSet Infusion Set 摘要 |
| K242763 | 2025-05-02 | Pfm Medical, Inc. | JetCan® Pro Safety Huber Needle 摘要 |
| K243529 | 2025-03-14 | Baxter Healthcare Corporation | Solution Administration Sets 摘要 |
| K242339 | 2025-02-28 | Baxter Healthcare Corporation | Intravascular Extension Sets and Accessories 摘要 |
| K241058 | 2024-12-18 | Quest Medical, Inc. | Lyka® PORT Needle Free Access Device (4170Y) 摘要 |
| K234129 | 2024-09-20 | Ecomed Solutions, LLC | Ecomed Disposable Administration Sets 摘要 |
| K242126 | 2024-08-22 | Bq Plus Medical Co., Ltd. | I.V. Administration Set |
| K232475 | 2024-05-10 | Shandong Zhushi Pharmaceutical Group C | Disposable infusion set with needle 摘要 |
| K222766 | 2024-04-12 | Shandong Ande Healthcare Apparatus Co. | Disposable Extension Set 摘要 |
| K232328 | 2024-03-01 | Innovative Health Sciences, LLC | Insignis Syringe Infusion System 摘要 |
| K231707 | 2024-01-03 | Q For Plastic Industries | ResQ Administration Set 摘要 |
| K230528 | 2023-12-01 | Medcaptain Life Science Co., Ltd. | Extension Set 摘要 |
| K222780 | 2023-11-09 | Lily Medical Corporation | LILY Extension Tube and Needleless Connector 摘要 |
| K230343 | 2023-11-03 | Epic Medical Pte. , Ltd. | ProSeal Closed System Administration Set 摘要 |
FDA 官方分类页： FPA
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。