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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K971975
Device Name CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER
Applicant
Cardima, Inc.
47266 Benicia St.
P.O. Box 14172
Fremont,  CA  94539
Applicant Contact JACK P DOUGLAS
Correspondent
Cardima, Inc.
47266 Benicia St.
P.O. Box 14172
Fremont,  CA  94539
Correspondent Contact JACK P DOUGLAS
Regulation Number870.1220
Classification Product Code
DRF  
Date Received05/29/1997
Decision Date 07/01/1998
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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