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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K902277
Device Name BARD EXTRACORPOREAL CIRCULATION CANNULAE
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Applicant Contact CHRISTINE MORGIDA
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Correspondent Contact CHRISTINE MORGIDA
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/21/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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