QJH
- 产品代码
- QJH
- 器械名称
- Reverse Central Venous Recanalization System
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.1342
- 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)
- 2 件
FDA 分类定义
A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252527 | 2025-09-10 | Merit Medical System, Inc. | Surfacer Inside-Out Access Catheter System |
FDA 官方分类页: QJH
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。