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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K993245
Device Name CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
Applicant
Alba Critical Care, Ltd.
Phoenix Crescent,
Strathclyde Business Park
Bellshill, Lanarkshire,  GB ML4 3NJ
Applicant Contact TED VANDER WIEDE
Correspondent
Alba Critical Care, Ltd.
Phoenix Crescent,
Strathclyde Business Park
Bellshill, Lanarkshire,  GB ML4 3NJ
Correspondent Contact TED VANDER WIEDE
Regulation Number870.1240
Classification Product Code
DYG  
Subsequent Product Code
DXG  
Date Received09/28/1999
Decision Date 10/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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