K872767

Substantially Equivalent

FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER

Applicant: Hospal Medical Corp.
Product code: KDI
Advisory panel: Gastroenterology, Urology
Date received: 1987-07-14
Decision date: 1987-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.