The following data is part of a premarket notification filed by Chengdu Daxan Innovative Medical Tech. Co., Ltd with the FDA for Pvc Hydrophilic Urethral Catheter.
| Device ID | K212567 |
| 510k Number | K212567 |
| Device Name: | PVC Hydrophilic Urethral Catheter |
| Classification | Catheter, Straight |
| Applicant | Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu, CN 611135 |
| Contact | Kevin Huang |
| Correspondent | Kevin Huang Chengdu Daxan Innovative Medical Tech. Co., Ltd Unit 6, Building 1, No.18, North Bayi Road, Wenjiang District Chengdu, CN 611135 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-12-07 |