Vial Adapter— 510(k) K260301

Substantially Equivalent

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

FDA 510(k) clearance K260301 for Vial Adapter, Substantially Equivalent on 2026-06-05. Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd..

Clearance details

Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2026-01-30
Decision date: 2026-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.