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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 K964248
Device Name HEARTPORT ENDOCORONARY SINUS CATHETR
Applicant
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Applicant Contact KEVIN F MACDONALD
Correspondent
HEARTPORT, INC.
200 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Correspondent Contact KEVIN F MACDONALD
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/24/1996
Decision Date 01/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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