DeviceClearance

K243607

Substantially Equivalent

Moda-flx Hemodialysis System™ Cartridge (102121-001 )

Applicant
Diality, Inc.
Product code
FJK
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK
Death
52
Malfunction
3,430
Total
3,482

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.