K221836

Substantially Equivalent

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

Applicant: Drägerwerk AG & Co. KGaA
Product code: CAH
Advisory panel: Anesthesiology
Date received: 2022-06-23
Decision date: 2022-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.