K192209

Substantially Equivalent

Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

Applicant: Fresenius Medical Care Renal Therapies Group, LLC
Product code: KPO
Advisory panel: Gastroenterology, Urology
Date received: 2019-08-14
Decision date: 2020-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, 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.