K260737
- 510(k) 号
- K260737
- 器械名称
- Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).
- 申请人
- Convatec GB
- 产品代码
- EZD — Catheter, Straight
- 批准日期
- 2026-08-05
- 受理日期
- 2026-03-06
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- Gastroenterology, Urology
FDA 官方记录: K260737
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。