Closed System Transfer Device— 510(k) K201460

Substantially Equivalent

Shinva Ande Healthcare Apparatus Co., Ltd.

FDA 510(k) clearance K201460 for Closed System Transfer Device, Substantially Equivalent on 2022-11-23. Applicant: Shinva Ande Healthcare Apparatus Co., Ltd..

Clearance details

Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
Product code: Code ONB
Advisory panel: General Hospital
Date received: 2020-06-02
Decision date: 2022-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zibo, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code ONB

product code ONB

Malfunction: 3,615
Other: 13
Total: 3,628

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.