TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-— 510(k) K850865

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K850865 for TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-, Substantially Equivalent on 1985-04-03. Applicant: Erika, Inc..

Clearance details

Applicant: Erika, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1985-03-01
Decision date: 1985-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, 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.