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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 K233397
Device Name Cosine-10TM Diagnostic Catheter
Applicant
Medtronic, Inc.
8200 Coreal Sea St. NE
Mvs3
Mounds View,  MN  55112
Applicant Contact Karine Lortie
Correspondent
Medtronic, Inc.
8200 Coreal Sea St. NE
Mvs3
Mounds View,  MN  55112
Correspondent Contact Karine Lortie
Regulation Number870.1220
Classification Product Code
DRF  
Date Received10/03/2023
Decision Date 12/02/2023
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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