OBJ
- 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.
该代码近三年的 510(k)(14 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261849 | 2026-07-24 | Luma Vision Limited | VERAFEYE Imaging Catheter (VF-VIC-002) | |
| K252945 | 2026-04-17 | Conavi Medical, Inc. | Novasight Hybrid System | |
| K260816 | 2026-04-08 | Boston Scientific | OptiCross Coronary Imaging Catheter (H749518110); Op | |
| K253399 | 2025-10-28 | Volcano Corporation (Dba Philips Image | Visions® PV .014P RX Digital IVUS Catheter ; Visions | |
| K250955 | 2025-10-22 | Yorlabs, Inc. | XC11 ICE System, USA | |
| K250913 | 2025-07-19 | Jiangsu Tingsn Technology Co., Ltd. | TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound | |
| K251211 | 2025-05-23 | ABBOTT MEDICAL | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocess | |
| K251231 | 2025-05-20 | ABBOTT MEDICAL | ViewFlex X ICE Catheter, Sensor Enabled | |
| K251103 | 2025-05-09 | Philips Image Guided Therapy Corporati | VeriSight Intracardiac Echocardiography Catheter (VS | |
| K242893 | 2025-03-24 | Luma Vision Limited | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE | |
| K241540 | 2024-06-28 | Biosense Webster, Inc. | NUVISION Ultrasound Catheter; NUVISION NAV Ultraso | |
| K240050 | 2024-06-12 | Biosense Webster, Inc. | SOUNDSTAR CRYSTAL Ultrasound Catheter | |
| K233948 | 2024-04-23 | Provisio Medical, Inc. | Provisio SLT IVUS System | |
| K233270 | 2023-10-28 | Siemens Medical Solutions USA, Inc. | AcuNav Crystal Ultrasound Catheter |
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。