K993245

Substantially Equivalent

CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM

Applicant: Alba Critical Care, Ltd.
Product code: DYG
Advisory panel: Cardiovascular
Date received: 1999-09-28
Decision date: 1999-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Bellshill, Lanarkshire, GB

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.