QEW
- 产品代码
- QEW
- 器械名称
- Peripheral Mechanical Thrombectomy With Aspiration
- 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
- 该代码近三年的 510(k)
- 143 件
FDA 分类定义
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
该代码近三年的 510(k)(37 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K262538 | 2026-08-21 | Inari Medical, Inc. | Artix MT;Artix Thin-Walled Sheath | FDA |
| K261523 | 2026-08-04 | Jupiter Endovascular | Vertex Thrombectomy System | |
| K260599 | 2026-04-24 | Penumbra, Inc. | INDIGO® Aspiration System INDIGO Link | |
| K251949 | 2026-02-05 | Penumbra, Inc. | INDIGO® Aspiration System - Lightning Flash Aspirati | |
| K260028 | 2026-02-05 | Argon Medical Devices, Inc. | CLEANER Vac Thrombectomy System, CLEANER Vac Aspir | |
| K253730 | 2026-01-21 | Verge Medical, Inc. | RoVo Mechanical Thrombectomy System | |
| K251207 | 2026-01-07 | Avantec Vascular Corporation | Sangria Thrombectomy System | |
| K252956 | 2025-12-18 | Endovascular Engineering, Inc. | Helo Thrombectomy System | |
| K251070 | 2025-11-25 | Akura Medical | Akura Thrombectomy System | |
| K253323 | 2025-10-29 | Inari Medical | Protrieve Sheath | |
| K251185 | 2025-10-22 | Intervene | Recana Thrombectomy Catheter System (FG014. FG015, F | |
| K252612 | 2025-10-16 | Penumbra, Inc. | INDIGO® Aspiration System Lightning Flash Aspirati | |
| K252057 | 2025-08-28 | Imperative Care, Inc. | Symphony Thrombectomy System and Symphony 16F 82cm | |
| K251189 | 2025-06-13 | Inquis Medical | Aventus Thrombectomy System | |
| K251485 | 2025-06-13 | Contego Medical, Inc. | Excipio LV Prime Thrombectomy Device | |
| K250787 | 2025-06-11 | Medtronic, Ireland | Liberant Thrombectomy System | |
| K250775 | 2025-05-14 | Imperative Care, Inc. | Symphony Thrombectomy System; Symphony 16F 82cm Th | |
| K250421 | 2025-05-12 | Inari Medical, Inc. | InThrill Thrombectomy System | |
| K250668 | 2025-03-25 | Inquis Medical | Aventus Thrombectomy System (IM-2100) | |
| K250088 | 2025-03-13 | Inari Medical, Inc. | FlowTriever2 Catheter | |
| K250202 | 2025-02-26 | Inquis Medical | Aventus Thrombectomy System | |
| K241894 | 2024-10-15 | Inari Medical, Inc. | Artix MT; Artix Thin-Walled Thrombectomy Sheath | |
| K242557 | 2024-09-27 | Inari Medical, Inc. | ClotTriever XL Catheter (41-102) | |
| K242075 | 2024-09-25 | Penumbra, Inc. | Indigo® Aspiration System Lightning Bolt Aspiratio | |
| K241362 | 2024-09-11 | Surmodics,Inc. | Pounce XL Thrombectomy System (PTS-1011-7F135) | |
| K242319 | 2024-09-03 | Penumbra, Inc. | Indigo® Aspiration System Aspiration Catheter 6X | |
| K233917 | 2024-07-18 | Ichor | ICHOR 7F Embolectomy System (ICH-7F) | |
| K241399 | 2024-06-10 | Penumbra, Inc. | Indigo® Lightning Flash Aspiration System Select + | |
| K241207 | 2024-05-29 | Devoro Medical, Inc. | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), | |
| K234073 | 2024-04-19 | Expanse Medical, Inc. | ICE Aspiration System | |
| K233909 | 2024-03-28 | Argon Medical Devices, Inc. | Cleaner Plus 18F Thrombectomy System - Cleaner Plu | |
| K240117 | 2024-03-15 | Inquis Medical | Aventus Thrombectomy System (IM-2001/IM-0002) | FDA |
| K234034 | 2024-02-09 | Inari Medical, Inc. | VenaCore Thrombectomy Catheter (46-101) | |
| K240030 | 2024-02-02 | Penumbra, Inc. | Indigo® Aspiration System - Lightning® Flash | |
| K232679 | 2024-01-19 | Argon Medical Devices, Inc. | Cleaner Pro Thrombectomy System; Cleaner Pro Aspir | |
| K233815 | 2023-12-18 | Inari Medical, Inc. | ClotTriever Sheath | |
| K232730 | 2023-11-01 | Inquis Medical | Aventus Thrombectomy System |
FDA 官方分类页: QEW
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。