510(k) K243175
K243175 is an FDA 510(k) premarket notification submitted by Chengdu Daxan Innovative Medical Tech. Co., Ltd. for the device "Disposable Intermittent Catheter (TPU Catheter)". The FDA issued a decision of Substantially Equivalent on June 26, 2025. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Chengdu Daxan Innovative Medical Tech. Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2025
- Date Received
- September 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type