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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 K981009
Device Name HEARTPORT ENDOPULMONARY VENT CATHETER
Original Applicant
HEARTPORT, INC.
700 bay rd.
redwood city,  CA  94063
Original Contact marianne d drennan
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/18/1998
Decision Date 09/04/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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