NIKKICART— 510(k) K221652

Substantially Equivalent

Renal Care Dialysis Solutions, S.A. DE C.V.

FDA 510(k) clearance K221652 for NIKKICART, Substantially Equivalent on 2023-03-03. Applicant: Renal Care Dialysis Solutions, S.A. DE C.V..

Clearance details

Applicant: Renal Care Dialysis Solutions, S.A. DE C.V.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2022-06-07
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Marques, MX

Download summary PDF View on FDA.gov ↗

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.