DeviceClearance

K190459

Substantially Equivalent

Hemoflow F3 and F4 Dialyzers

Applicant
Fresenius Medical Care Renal Therapies Group, LLC
Product code
FJI
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waltham, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FJI

product code FJI
Death
2
Total
2

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.