510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993245Substantially Equivalent

Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom

Alba Critical Care, Ltd., Bellshill, Lanarkshire, GB / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993245 is the FDA 510(k) clearance record for CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM, a class II device, cleared for Alba Critical Care, Ltd. on under FDA product code DYG (Catheter, Flow Directed). FDA records list one 510(k) clearance for Alba Critical Care, Ltd. As of , FDA records show no recalls naming K993245.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
Device class
Class II
Review panel
Cardiovascular
Applicant
Alba Critical Care, Ltd. Phoenix Crescent,, Bellshill, Lanarkshire, GB
510(k) summary
Summary
Third party review
No

Clearances, product code DYG

Trailing 12 months

FDA records hold no clearances under product code DYG in the trailing twelve months.

FDA records show no clearances under product code DYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260