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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K974175
Device Name HEARTPORT ENDOAORTIC CLAMP CATHETER
Applicant
Heartport, Inc.
200 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact MARIANNE C DRENNAN
Correspondent
Heartport, Inc.
200 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact MARIANNE C DRENNAN
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received11/06/1997
Decision Date 12/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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