A-15 HEMODIALYZER— 510(k) K992594

Name: FDA 510(k) clearance K992594
Creator: U.S. Food and Drug Administration
Published: 1999-09-24

Substantially Equivalent

Althin Medical AB

FDA 510(k) clearance K992594 for A-15 HEMODIALYZER, Substantially Equivalent on 1999-09-24. Applicant: Althin Medical AB. Device class: 2.

Clearance details

Applicant: Althin Medical AB
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-03
Decision date: 1999-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronneby, SE

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.