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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K820297
Device Name WM. HARVEY OVERPRESSURE SAFETY VALVE
Applicant
C.R. BARD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
C.R. BARD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4290
Classification Product Code
DTL  
Date Received02/04/1982
Decision Date 03/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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