FDA 510(k) Application Details - K233433

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K233433
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	Medtronic 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Matthew Lobeck Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	MTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/2023
Decision Date	08/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review