CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM— 510(k) K993245

Substantially Equivalent

Alba Critical Care, Ltd.

FDA 510(k) clearance K993245 for CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM, Substantially Equivalent on 1999-10-28. Applicant: Alba Critical Care, Ltd..

Clearance details

Applicant: Alba Critical Care, Ltd.
Product code: 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

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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.