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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K821442
Device Name WILLIAM HARVEY FLEX. VENOUS RESERVOIR
Applicant
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Correspondent
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Regulation Number870.4400
Classification Product Code
DTN  
Date Received05/13/1982
Decision Date 06/17/1982
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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