A-22 HEMODIALYZER— 510(k) K992563

Substantially Equivalent

Althin Medical AB

FDA 510(k) clearance K992563 for A-22 HEMODIALYZER, Substantially Equivalent on 2000-01-18. Applicant: Althin Medical AB.

Clearance details

Applicant: Althin Medical AB
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-02
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronneby, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.