510(k) K014140— RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

Substantially Equivalent

Sunder Biomedical Tech. Co., Ltd.

Clearance details

Applicant: Sunder Biomedical Tech. Co., Ltd.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2001-12-17
Decision date: 2002-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

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.