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510(k) K233433

Sphere-9Dx Diagnostic Catheter (AFR-00009) by Medtronic — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2024
Date Received
October 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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