ALTHIN MEDICAL AB ALTRACART II— 510(k) K990010

Name: FDA 510(k) clearance K990010
Creator: U.S. Food and Drug Administration
Published: 1999-04-15

Substantially Equivalent

Althin Medical AB

FDA 510(k) clearance K990010 for ALTHIN MEDICAL AB ALTRACART II, Substantially Equivalent on 1999-04-15. Applicant: Althin Medical AB. Device class: 2.

Clearance details

Applicant: Althin Medical AB
Product code: Code KPO
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-01-04
Decision date: 1999-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 372 21 Ronneby, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.