DWF
- 产品代码
- DWF
- 器械名称
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.4210
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 401 件
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 |
|---|---|---|---|
| K260195 | 2026-04-23 | Medtronic, Inc. | Elongated One-Piece Arterial (EOPA) 3D Arterial Can 摘要 |
| K250937 | 2026-03-11 | LivaNova USA, Inc. | Venous Return Cannulae 摘要 |
| K260043 | 2026-02-23 | Smart Reactors | Smart Reactors Camouflage Coated Extracorporeal Card 摘要 |
| K253203 | 2026-02-19 | Medtronic, Inc. | Retrograde Coronary Sinus Perfusion Cannulae 摘要 |
| K253671 | 2026-01-30 | Sorin Group Italia S.R.L. | Dual Stage Venous Cannulae 摘要 |
| K253998 | 2026-01-20 | Medtronic, Inc. | Clearview Intracoronary Shunts 摘要 |
| K253106 | 2025-10-24 | AngioDynamics, Inc. | AngioVac Cannula 摘要 |
| K250283 | 2025-07-10 | LivaNova USA, Inc. | RAP Femoral Venous Cannulae 摘要 |
| K250610 | 2025-06-27 | Sorin Group Italia S.R.L. | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 摘要 |
| K251258 | 2025-06-20 | Medtronic, Inc. | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Ven 摘要 |
| K241248 | 2024-05-31 | Spectrum Medical S.R.L. | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V 摘要 |
| K240193 | 2024-02-22 | Sorin Group Italia S.R.L. | R501 - R502 aortic root cannulae with and without ve 摘要 |
| K233895 | 2024-02-05 | Edwards Lifesciences | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, 摘要 |
| K231206 | 2023-12-07 | Medtronic, Inc. | DLP Silicone Coronary Artery Ostial Cannulae 摘要 |
FDA 官方分类页： DWF
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。