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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 K190132
Device Name Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
Applicant
Medtronic
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact Matthew Lobeck
Correspondent
Medtronic
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact Matthew Lobeck
Regulation Number870.1220
Classification Product Code
DRF  
Date Received01/28/2019
Decision Date 07/30/2019
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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