K120823

Substantially Equivalent

BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS

Applicant: Fresenius Medical Care North America, Design Cente
Product code: FJK
Advisory panel: Gastroenterology, Urology
Date received: 2012-03-19
Decision date: 2012-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, 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.