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KRD

Device, Vascular, For Promoting Embolization

产品代码
KRD
器械名称
Device, Vascular, For Promoting Embolization
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 870.3300
FDA 专业组
Cardiovascular
上市路径
需提交 510(k) 上市前通告
标记
属植入器械
该代码近三年的 510(k)
22 件
其中 Summary 已存档
21 份,可直接下载
FDA 历史累计 510(k)
132 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)(22 件)

数据窗口为最近三年。最新一件:2026-07-31。

510(k) 号批准日期申请人器械名称摘要
K2528122026-07-31Suzhou Haowei Medical Technology Co., …UniPearls® Embolic MicrospheresPDF
K2614882026-07-24Boston Scientific CorporationOBSIDIO Conformable EmbolicPDF
K2618662026-06-24Medtronic, Inc.Concerto Versa™ Detachable CoilPDF
K2606352026-06-12Nuvascular, Inc.HARBOR Occlusion DevicePDF
K2605082026-04-10Okami Medical, Inc.LOBO Vascular Occlusion SystemPDF
K2535112026-01-14Medtronic, Inc.Concerto Versa™ Detachable CoilPDF
K2536772025-12-15Instylla, Inc.Tembo Embolic SystemPDF
K2533762025-10-30Boston Scientific CorporationOBSIDIO™ Conformable Embolic (M0013972101010)PDF
K2502092025-09-23Canyon Medical, Inc.Polyvinyl Alcohol Embolic MicrospheresPDF
K2501332025-07-09Nuvascular, Inc.HARBOR Occlusion DevicePDF
K2513832025-05-30Balt USA, LLCPrestige Coil System (Prestige Packing Line Extensio…PDF
K2509712025-05-16Biosphere Medical, S.A.Embosphere MicrospheresPDF
K2502762025-05-15Embolization, Inc.Nitinol Enhanced Device (NED)PDF
K2500792025-03-14Penumbra, Inc.Ruby XL SystemPDF
K2426082025-01-17Varian Medical Systems, Inc.Embozene Color-Advanced MicrospheresFDA
K2408732024-12-16Instylla, Inc.TEMBO Embolic SystemPDF
K2427942024-10-16Varian Medical Systems, Inc.ONCOZENE MicrospheresPDF
K2425072024-10-03Boston ScientificOBSIDIO™ Conformable EmbolicPDF
K2329342024-05-30Hangzhou Yangshun Medical Technology C…SunspherePDF
K2402612024-05-02Merit Medical Systems, Inc.Siege Vascular Plug (SVP2.5-0.021); Siege Vascular P…PDF
K2341232024-02-13Abk Biomedical, Inc.Easi-Vue® embolic microspheres SystemPDF
K2315542023-11-14Suzhou Haowei Medical Technology Co., …UniPearls® Embolic MicrospheresPDF

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: KRD
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。