DeviceClearance

K850865

Substantially Equivalent

TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-

Applicant
Erika, Inc.
Product code
FJI
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockleigh, NJ, 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.