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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K972570
Device Name HEARTPORT INTRODUCER SHEATH
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 Number870.1340
Classification Product Code
DYB  
Date Received07/10/1997
Decision Date 10/01/1997
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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