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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Rhodamine, Antigen, Antiserum, Control
510(k) Number K023368
Device Name TRUCATH.IP
Applicant
Aortech Critical Care , Ltd.
Phoenix Crescent,
Strathclyde Business Park
Bellshill, Lanarkshire,  GB ML4 3NJ
Applicant Contact PAUL BURNS
Correspondent
Aortech Critical Care , Ltd.
Phoenix Crescent,
Strathclyde Business Park
Bellshill, Lanarkshire,  GB ML4 3NJ
Correspondent Contact PAUL BURNS
Regulation Number866.5550
Classification Product Code
DFG  
Date Received10/08/2002
Decision Date 10/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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