K062079

Substantially Equivalent

XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210

Applicant: Baxter Healthcare Corporation
Product code: KDI
Advisory panel: Gastroenterology, Urology
Date received: 2006-07-21
Decision date: 2006-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.