CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER— 510(k) K982337

Name: FDA 510(k) clearance K982337
Creator: U.S. Food and Drug Administration
Published: 1998-12-29

Substantially Equivalent

Haidylena Medical Egypt

FDA 510(k) clearance K982337 for CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER, Substantially Equivalent on 1998-12-29. Applicant: Haidylena Medical Egypt. Device class: 2.

Clearance details

Applicant: Haidylena Medical Egypt
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1998-07-06
Decision date: 1998-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nasr City, Cairo, EG

Download summary PDF View on FDA.gov ↗

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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 →

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