QEZ
- 产品代码
- QEZ
- 器械名称
- Aspiration Thrombectomy Catheter
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.5150
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 豁免 GMP(质量体系)
- 该代码近三年的 510(k)
- 94 件
FDA 分类定义
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
该代码近三年的 510(k)(12 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261105 | 2026-07-27 | Inquis Medical | Powered Aventus Thrombectomy System | |
| K262030 | 2026-07-15 | Inquis Medical | Aventus Thrombectomy System | |
| K253589 | 2026-04-23 | Medtronic Interventional Vascular, Inc | Liberant RX Aspiration Catheter | |
| K254208 | 2026-03-20 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | |
| K253925 | 2026-01-15 | Inquis Medical | Aventus Thrombectomy System | |
| K252509 | 2025-11-24 | AngioDynamics, Inc. | AlphaVac Multipurpose Mechanical Aspiration System F | |
| K251312 | 2025-10-24 | Vesalio, Inc. | Vesalio Peripheral System | |
| K251488 | 2025-07-14 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | |
| K243549 | 2025-04-04 | ABBOTT MEDICAL | JETi Hydrodynamic Thrombectomy System | |
| K250013 | 2025-03-24 | Control Medical Technology, Inc. / Dba | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System ( | |
| K240397 | 2024-04-01 | AngioDynamics, Inc. | AlphaVac MMA F1885 System (H787253020) | |
| K232458 | 2023-12-19 | ABBOTT MEDICAL | JETiHydrodynamic Thrombectomy System | FDA |
FDA 官方分类页: QEZ
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。