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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 K974683
Device Name NAVIPORT DEFLECTABLE TIP GUIDING CATHETER
Applicant
Cardima, Inc.
47266 Benicia St.
Fremont,  CA  94538
Applicant Contact SHELLEY TRIMM
Correspondent
Cardima, Inc.
47266 Benicia St.
Fremont,  CA  94538
Correspondent Contact SHELLEY TRIMM
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/16/1997
Decision Date 06/22/1999
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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