ARTIFICIAL KIDNEY, C-DAK 0.6D— 510(k) K782151

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K782151 for ARTIFICIAL KIDNEY, C-DAK 0.6D, Substantially Equivalent on 1979-02-22. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1978-12-26
Decision date: 1979-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.