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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K973298
Device Name CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
Applicant
CARDIMA, INC.
47266 BENICIA ST.
FREMONT,  CA  94538 -1372
Applicant Contact SHELLEY TRIMM
Correspondent
CARDIMA, INC.
47266 BENICIA ST.
FREMONT,  CA  94538 -1372
Correspondent Contact SHELLEY TRIMM
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/02/1997
Decision Date 06/26/1998
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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