LOX
- 产品代码
- LOX
- 器械名称
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.5100
- 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)
- 88 件
FDA 分类定义
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
该代码近三年的 510(k)（10 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261428 | 2026-08-14 | Medtronic Ireland | NC Euphora Rapid Exchange Balloon Dilatation Cathete 摘要 |
| K261759 | 2026-07-27 | Medtronic Ireland | Euphora Rapid Exchange (RX) Balloon Dilatation Cathe 摘要 |
| K252116 | 2026-04-07 | Shanghai MicroPort Medical (Group) Co. | Firefighter Pro PTCA Balloon Catheter 摘要 |
| K254022 | 2026-04-02 | Verge Medical, Inc. | FLASH Flex Aorto-Ostial Angioplasty System 摘要 |
| K252295 | 2026-03-27 | Terumo Corporation | Ryurei 摘要 |
| K251970 | 2026-01-17 | Medtronic, Ireland | Sprinter Legend Rapid Exchange Balloon Dilatation Ca 摘要 |
| K242969 | 2024-10-25 | Biotronik, Inc. | Pantera Pro; Pantera LEO 摘要 |
| K233499 | 2024-08-16 | OrbusNeich Medical (Shenzhen) Co., Ltd | Sapphire NC ULTRA Coronary Dilatation Catheter 摘要 |
| K233505 | 2024-08-15 | OrbusNeich Medical (Shenzhen) Co., Ltd | Sapphire ULTRA Coronary Dilatation Catheter 摘要 |
| K233729 | 2024-05-31 | Vascular Solutions, LLC | Ringer perfusion balloon catheter, 2.00 x 20mm (5881 摘要 |
FDA 官方分类页： LOX
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。