OBJ

Catheter, Ultrasound, Intravascular

产品代码
OBJ
器械名称
Catheter, Ultrasound, Intravascular
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 870.1200
FDA 专业组
Cardiovascular
上市路径
需提交 510(k) 上市前通告
该代码近三年的 510(k)
79 件

FDA 分类定义

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(14 件)

数据窗口为最近三年。最新一件:2026-07-24。

510(k) 号批准日期申请人器械名称摘要
K2618492026-07-24Luma Vision LimitedVERAFEYE Imaging Catheter (VF-VIC-002)PDF
K2529452026-04-17Conavi Medical, Inc.Novasight Hybrid SystemPDF
K2608162026-04-08Boston ScientificOptiCross Coronary Imaging Catheter (H749518110); OpPDF
K2533992025-10-28Volcano Corporation (Dba Philips ImageVisions® PV .014P RX Digital IVUS Catheter ; VisionsPDF
K2509552025-10-22Yorlabs, Inc.XC11 ICE System, USAPDF
K2509132025-07-19Jiangsu Tingsn Technology Co., Ltd.TINGSN FINDERS 2 Color Doppler Diagnostic UltrasoundPDF
K2512112025-05-23ABBOTT MEDICALViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco ReprocessPDF
K2512312025-05-20ABBOTT MEDICALViewFlex™ X ICE Catheter, Sensor Enabled™PDF
K2511032025-05-09Philips Image Guided Therapy CorporatiVeriSight Intracardiac Echocardiography Catheter (VSPDF
K2428932025-03-24Luma Vision LimitedVERAFEYE System VERAFEYE Imaging Catheter & VERAFEYEPDF
K2415402024-06-28Biosense Webster, Inc.NUVISION™ Ultrasound Catheter; NUVISION™ NAV UltrasoPDF
K2400502024-06-12Biosense Webster, Inc.SOUNDSTAR™ CRYSTAL Ultrasound CatheterPDF
K2339482024-04-23Provisio Medical, Inc.Provisio™ SLT IVUS™ SystemPDF
K2332702023-10-28Siemens Medical Solutions USA, Inc.AcuNav Crystal Ultrasound CatheterPDF

其中 14 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: OBJ
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。