CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM— 510(k) K993245
Substantially EquivalentAlba 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.. Device class: 2.
Clearance details
- Applicant
- Alba Critical Care, Ltd.
- Product code
- Code DYG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bellshill, Lanarkshire, GB
Recent devices under product code DYG
view all- K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more
- K233983 — Swan-Ganz Pacing Probe and Catheters +4 more
- K233824 — Swan-Ganz catheter
- K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
- K222117 — Swang-Ganz IQ pulmonary artery catheter
Adverse events under product code DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
Source: openFDA MAUDE database, through . 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.