AMICUS Separator System— 510(k) K192150

Substantially Equivalent

Fresenius Kabi AG

FDA 510(k) clearance K192150 for AMICUS Separator System, Substantially Equivalent on 2019-11-13. Applicant: Fresenius Kabi AG.

Clearance details

Applicant: Fresenius Kabi AG
Product code: Code LKN
Advisory panel: Unknown
Date received: 2019-08-09
Decision date: 2019-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bad Homburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 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.