PTK
- 产品代码
- PTK
- 器械名称
- Pediatric Esophageal Atresia Anastomosis Device
- 管理类别
- 第 3 类（Class III）
- 21 CFR 条款
- 21 CFR 876.5980
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- HDE - Humanitarian Device Exemption
- 标记
- 属生命支持/维持器械
FDA 分类定义
Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.
FDA 官方分类页： PTK
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。