WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE— 510(k) K941958

Substantially Equivalent

Western Dialysis Supplies , Ltd.

FDA 510(k) clearance K941958 for WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE, Substantially Equivalent on 1994-09-30. Applicant: Western Dialysis Supplies , Ltd..

Clearance details

Applicant: Western Dialysis Supplies , Ltd.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-22
Decision date: 1994-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Calgary, Alberta, CA

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.