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FPA

Set, Administration, Intravascular

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)
24 件
其中 Summary 已存档
21 份,可直接下载
FDA 历史累计 510(k)
1174 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)(24 件)

数据窗口为最近三年。最新一件:2026-06-03。

510(k) 号批准日期申请人器械名称摘要
K2615302026-06-03Deka Research and DevelopmentiiSure Infusion SetPDF
K2525432026-05-04Amsino International, Inc.AMSafe Administration Set (BA-70075, BA-70071-D, BA-…PDF
K2513752026-02-12Puracath Medical, Inc.PuraCath Firefly Needleless Connector IT (9005)PDF
K2512572025-12-04Np MedicalnSet+ Stabilization Set [6426733]; nSet+ Stabilizati…PDF
K2503252025-10-30Carefusion (Bd)BD Alaris Pump Infusion SetPDF
K2518142025-08-29Epic Medical Pte. , Ltd.EZ™ IV Administration SetPDF
K2518542025-08-06Tandem Diabetes CareSteadiSet infusion setPDF
K2438412025-08-01Deka Research and DevelopmentSparta Infusion Set for InsulinFDA
K2433922025-07-24B.Braun Medical, Inc.Infusomat® Space Volumetric Infusion Pump Administra…PDF
K2506162025-06-05Icu Medical, Inc.Clave™ Neutral-Displacement Needlefree ConnectorsPDF
K2426922025-05-09Capillary Biomedical, LLCSteadiSet Infusion SetPDF
K2427632025-05-02Pfm Medical, Inc.JetCan® Pro Safety Huber NeedlePDF
K2435292025-03-14Baxter Healthcare CorporationSolution Administration SetsPDF
K2423392025-02-28Baxter Healthcare CorporationIntravascular Extension Sets and AccessoriesPDF
K2410582024-12-18Quest Medical, Inc.Lyka® PORT Needle Free Access Device (4170Y)PDF
K2341292024-09-20Ecomed Solutions, LLCEcomed Disposable Administration SetsPDF
K2421262024-08-22Bq Plus Medical Co., Ltd.I.V. Administration Set—
K2324752024-05-10Shandong Zhushi Pharmaceutical Group C…Disposable infusion set with needleFDA
K2227662024-04-12Shandong Ande Healthcare Apparatus Co.…Disposable Extension SetPDF
K2323282024-03-01Innovative Health Sciences, LLCInsignis™ Syringe Infusion SystemPDF
K2317072024-01-03Q For Plastic IndustriesResQ Administration SetPDF
K2305282023-12-01Medcaptain Life Science Co., Ltd.Extension SetPDF
K2227802023-11-09Lily Medical CorporationLILY Extension Tube and Needleless ConnectorPDF
K2303432023-11-03Epic Medical Pte. , Ltd.ProSeal™ Closed System Administration SetPDF

其中 21 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: 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。