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 |