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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 K101955
Device Name ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Applicant Contact WENDY PINOR
Correspondent
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Correspondent Contact WENDY PINOR
Regulation Number870.1220
Classification Product Code
DRF  
Date Received07/12/2010
Decision Date 10/15/2010
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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