BAXTER CA DIALYZER— 510(k) K926567

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K926567 for BAXTER CA DIALYZER, Substantially Equivalent on 1995-01-11. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1992-12-31
Decision date: 1995-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.