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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K990795
Device Name MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES
Applicant
Cardiac Pathways Corp.
995 Benecia Ave.
Sunnyvale,  CA  94086
Applicant Contact ERIN DIGNAN
Correspondent
Cardiac Pathways Corp.
995 Benecia Ave.
Sunnyvale,  CA  94086
Correspondent Contact ERIN DIGNAN
Regulation Number870.1220
Classification Product Code
MTD  
Date Received03/10/1999
Decision Date 06/08/1999
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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