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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 K962366
Device Name HEARTPORT CABLE BULLDOG CLAMP
Applicant
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Applicant Contact ISABELLA R ABATI, M.S.
Correspondent
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Correspondent Contact ISABELLA R ABATI, M.S.
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/19/1996
Decision Date 11/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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