FDA 510(k) Application Details - K201806

Device Classification Name	Catheter,Intracardiac Mapping,High-Density Array   More FDA Info for this Device
510(K) Number	K201806
Device Name	Catheter,Intracardiac Mapping,High-Density Array
Applicant	Sterilmed Inc. (Johnson and Johnson) 5010 Cheshire Parkway N, Suite 2 Plymouth, MN 55446 US Other 510(k) Applications for this Company
Contact	Jan Flegeau 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	07/01/2020
Decision Date	06/23/2021
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