DeviceClearance

K180615

Substantially Equivalent

AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter

Applicant
Fresenius Kabi USA,Llc
Product code
LKN
Advisory panel
Unknown
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 LKN

product code LKN
Death
50
Injury
314
Total
364

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.