K202459

Substantially Equivalent

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter

Applicant: Pharma System AB
Product code: CAH
Advisory panel: Anesthesiology
Date received: 2020-08-27
Decision date: 2021-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knivsta, SE

Download summary PDF View on FDA.gov ↗

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.