FDA 510(k) Application Details - K241372

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K241372
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	Abbott Medical 5050 Nathan Lane North Plymouth, MN 55442 US Other 510(k) Applications for this Company
Contact	Samantha Stretar 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	05/15/2024
Decision Date	07/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review