PVC Hydrophilic Urethral Catheter— 510(k) K212567

Substantially Equivalent

Chengdu Daxan Innovative Medical Tech. Co., Ltd.

FDA 510(k) clearance K212567 for PVC Hydrophilic Urethral Catheter, Substantially Equivalent on 2022-12-07. Applicant: Chengdu Daxan Innovative Medical Tech. Co., Ltd..

Clearance details

Applicant: Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2021-08-16
Decision date: 2022-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chengdu, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.