K243175
- 510(k) number
- K243175
- Device name
- Disposable Intermittent Catheter (TPU Catheter)
- Applicant
- Chengdu Daxan Innovative Medical Tech. Co., Ltd. CN
- Product code
- EZD — Catheter, Straight
- Decision date
- 2025-06-26
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K243175.pdf
Official FDA record: K243175
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.