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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 K990772
Device Name DIRECTFLOW ARTERIAL CANNULA
Original Applicant
HEARTPORT, INC.
700 bay rd.
redwood city,  CA  94063
Original Contact marianne c drennan
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/09/1999
Decision Date 03/23/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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