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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 K022380
Device Name LIVESIRE ELECTROPHYSIOLOGY CATHETER
Applicant
St Jude Medical
14900 Minnetonka Industrial Bl
Minnetonka,  MN  55345
Applicant Contact JIM M TAUFEN
Correspondent
St Jude Medical
14900 Minnetonka Industrial Bl
Minnetonka,  MN  55345
Correspondent Contact JIM M TAUFEN
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/22/2002
Decision Date 10/01/2002
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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