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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K233433
Device Name Sphere-9Dx Diagnostic Catheter (AFR-00009)
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
MTD  
Date Received10/12/2023
Decision Date 08/07/2024
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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