K850406

Substantially Equivalent

AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM

Applicant: Travenol Laboratories, S.A.
Product code: FKX
Advisory panel: Gastroenterology, Urology
Date received: 1985-02-04
Decision date: 1985-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Adverse events under product code FKX

product code FKX

Death: 501
Injury: 6,720
Malfunction: 18,508
Other: 1
Total: 25,730

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.