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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 K961270
Device Name HEARTPORT ENDOSINUS CATHETER
Original Applicant
HEARTPORT, INC.
200 chesapeake dr.
redwood city,  CA  94063
Original Contact robert j chin
Regulation Number870.4210
Classification Product Code
DWF  
Date Received04/02/1996
Decision Date 06/18/1996
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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