510(k) K012242— FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

Substantially Equivalent

Fresenius Medical Care North America

Clearance details

Applicant: Fresenius Medical Care North America
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-17
Decision date: 2001-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.