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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K993376
Device Name ENSTYLET MODELS EC0010, EC0020
Applicant
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact JAMES BULLOCK
Correspondent
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Correspondent Contact JAMES BULLOCK
Regulation Number870.1380
Classification Product Code
DRB  
Date Received10/07/1999
Decision Date 01/05/2000
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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