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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 K994389
Device Name COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
Applicant
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Applicant Contact LYNNE LEONARD
Correspondent
COBE CARDIOVASCULAR, INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Correspondent Contact LYNNE LEONARD
Regulation Number870.4400
Classification Product Code
DTN  
Subsequent Product Code
DTP  
Date Received12/28/1999
Decision Date 03/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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