DORA Disposable A.V. Fistula Needle Sets— 510(k) K213015

Substantially Equivalent

Bain Medical Equipment (Guangzhou) Co., Ltd.

FDA 510(k) clearance K213015 for DORA Disposable A.V. Fistula Needle Sets, Substantially Equivalent on 2022-04-08. Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd..

Clearance details

Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-20
Decision date: 2022-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.