K131646

Substantially Equivalent

DISPOSABLE INFUSION SET

Applicant: Shanghai Jinta Medical Co., Ltd.
Product code: LHI
Advisory panel: General Hospital
Date received: 2013-06-05
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fengjing Town, Jinshan District, CN

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.