CATSmart, Automated Blood Processing Autotransfusion System— 510(k) K210089

Substantially Equivalent

Fresenius Kabi AG

FDA 510(k) clearance K210089 for CATSmart, Automated Blood Processing Autotransfusion System, Substantially Equivalent on 2021-02-11. Applicant: Fresenius Kabi AG.

Clearance details

Applicant: Fresenius Kabi AG
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 2021-01-13
Decision date: 2021-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Bad Homburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.