K030497

Substantially Equivalent

FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES

Applicant: Fresenius Medical Care
Product code: KPO
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-19
Decision date: 2003-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.