DeviceClearance

K200530

Substantially Equivalent

AMICUS Separator System

Applicant
Fresenius Kabi AG
Product code
GKT
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Zurich, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GKT

product code GKT
Death
167
Injury
301
Malfunction
2,086
Total
2,554

Source: openFDA MAUDE database, through . 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.