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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K962858
Device Name HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
Applicant
Heartport, Inc.
200 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact ROBERT J CHIN
Correspondent
Heartport, Inc.
200 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact ROBERT J CHIN
Regulation Number870.4450
Classification Product Code
DXC  
Date Received07/22/1996
Decision Date 09/30/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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