EXTRACORPOREAL BLOOD CIRCUIT— 510(k) K982340

Name: FDA 510(k) clearance K982340
Creator: U.S. Food and Drug Administration
Published: 1999-04-30

Substantially Equivalent

Haidylena Medical Egypt

FDA 510(k) clearance K982340 for EXTRACORPOREAL BLOOD CIRCUIT, Substantially Equivalent on 1999-04-30. Applicant: Haidylena Medical Egypt. Device class: 2.

Clearance details

Applicant: Haidylena Medical Egypt
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1998-07-06
Decision date: 1999-04-30
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 FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.