K854575

Substantially Equivalent

MODIFIED AM-SERIES DIALYZERS

Applicant: Asahi Medical Co., Ltd.
Product code: FJI
Advisory panel: Gastroenterology, Urology
Date received: 1985-11-06
Decision date: 1985-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Adverse events under product code FJI

product code FJI

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.