K181870

Substantially Equivalent

Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use

Applicant: Wuhan W.E.O Science & Technology Development Co., Ltd.
Product code: FPA
Advisory panel: General Hospital
Date received: 2018-07-12
Decision date: 2019-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhun, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.