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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 K983456
Device Name ENSITE 3000 SYSTEM
Applicant
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact ANDREW BALO
Correspondent
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Correspondent Contact ANDREW BALO
Regulation Number870.1220
Classification Product Code
MTD  
Subsequent Product Code
DQK  
Date Received09/30/1998
Decision Date 04/21/1999
Decision SE - With Limitations (SESU)
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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