K160735

Substantially Equivalent

CATSmart

Applicant: Fresenius Kabi AG
Product code: CAC
Advisory panel: Anesthesiology
Date received: 2016-03-17
Decision date: 2016-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bad Homburg, DE

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.