SDB
- 产品代码
- SDB
- 器械名称
- Tracheal Prosthesis With Cover Material Derived From Human Sources
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 868.3721
- FDA 专业组
- Anesthesiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 1 件
- 其中 Summary 已存档
- 0 份，可直接下载
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
The tracheal prosthesis with cover material derived from human sources is an expandable tubular device made of a metal material covered with a human-sourced decellularized material. It is intended to be implanted to restore the structure and/or function of the trachea or tracheobronchial tree. This device may also include a device delivery system. This device type does not include products that are intended to promote regeneration, impede inflammatory cascades, and release growth factors.
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 |
|---|---|---|---|---|
| DEN230087 | 2024-10-16 | Peytant Solutions, Inc. | AMStent® Tracheobronchial Covered Stent System | — |
FDA 官方分类页： SDB
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。