K920797

Substantially Equivalent

HEMODIALYSIS BLOOD TUBING SET

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: FJK
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-21
Decision date: 1992-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, 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.